Accepted Manuscript Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burow's Triangle in the Treatment of Pilonidal Sinus Disease Mehmet Saydam, M.D, Bulent Ozturk, M.D, Huseyin Sinan, M.D, Associate Professor, Ahmet Z. Balta, M.D, Pervin Demir, Research Assistant, Mustafa T. Ozer, Associate Professor, Sezai Demirbas, Professor PII:
S0002-9610(15)00331-1
DOI:
10.1016/j.amjsurg.2015.03.031
Reference:
AJS 11557
To appear in:
The American Journal of Surgery
Received Date: 2 October 2014 Revised Date:
20 March 2015
Accepted Date: 30 March 2015
Please cite this article as: Saydam M, Ozturk B, Sinan H, Balta AZ, Demir P, Ozer MT, Demirbas S, Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burow's Triangle in the Treatment of Pilonidal Sinus Disease, The American Journal of Surgery (2015), doi: 10.1016/j.amjsurg.2015.03.031. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Word count for the abstract: 299 STRUCTURED ABSTRACT
Background: Although many options exist for surgical treatment of pilonidal sinus
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disease (PSD), consensus has not yet been achieved, as all surgical methods have various rates of complications, postoperative infection, and recurrence.
Objective: This study compared two surgical treatments for PSD: modified Limberg
Design: Prospective, randomized, clinical trial.
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flap transposition and lateral advancement flap transposition with Burow's triangle.
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Setting: Ankara Mevki Military Hospital General Surgery Service
Patients: Consecutive 100 patients admitted to hospital for treatment of PSD from May 2013 to August 2013.
Interventions: The patients received surgical treatment with either modified Limberg
triangle (n=50).
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flap transposition (n=50) or lateral advancement flap transposition with Burow’s
Main Outcome Measures: Clinical healing period; length of hospital stay; operative
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time; postoperative complications including recurrence, wound dehiscence, surgical site infection, as noted during postoperative follow-up period; Visual Analog Scale
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(VAS) scores for pain.
Results: The mean follow-up period was 12 months. No significant differences were observed between the two groups in length of hospital stay (p=0.515), operative time (p=0.175), wound dehiscence (p=0.645), and VAS pain scores (p=0.112). The mean operative times were 42.5 minutes in the modified Limberg group and 40.0 minutes in the lateral advancement group. Limitations: No questionnaire was offered to the patients about their postoperative aesthetic satisfaction. A further study on this aspect may be useful.
ACCEPTED MANUSCRIPT Conclusions: Although lateral advancement flap transposition with Burow's triangle is used less often than modified Limberg flap transposition, we could not determine a parameter that was statistically different such as operative time, postoperative complication or the length of hospital stay. Hence, the lateral advancement flap is as
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viable an option as other more preferable techniques in the treatment of PSD which particularly settled on the upper segment without a deep natal cleft.
Keywords: Pilonidal sinus disease; Lateral advancement; modified Limberg; Burow; Surgical
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treatment.
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Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burow's Triangle in the Treatment of Pilonidal Sinus Disease
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Conflicts of interest: None
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Financial support: None
Authors List:
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1-Mehmet SAYDAM, M.D., (The Corresponding Author)
Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100 TURKEY
Email:msaydam@2008 hotmail.com Tel:+905344535319 Fax:+903123113535
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2-Bulent OZTURK, M.D., (Contribution of Acquisition of Data)
Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100 TURKEY
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3-Huseyin SINAN, Associate Professor M.D., (Contribution of Conseption and Design) Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100
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TURKEY
4-Ahmet Z. BALTA, M.D., (Contribution of Conseption and Design) Istanbul Gulhane Haydarpasa Medical Training Hospital, Deparment of General Surgery Istanbul, 34668, TURKEY 5-Pervin Demir, Research Assistant, (Contribution of Drafting The Article) Yıldırım Beyazıt University, Department of Medical Biostatistics , Dıskapı, 061100, Ankara, TURKEY
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6-Mustafa T. OZER, Associate Professor, (Contribution of Revising The Manuscipt Critically) Gulhane Military Medical Academy, Department of General Surgery, Etlik, 06100, Ankara, TURKEY
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7-Sezai DEMIRBAS, Professor, (Contribution of Approval of The Manuscript)
Gulhane Military Medical Academy, Department of General Surgery, Etlik, 06100, Ankara, TURKEY
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Word count for the manuscript: 2694
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ACCEPTED MANUSCRIPT INTRODUCTION
Pilonidal Sinus Disease (PSD) is a common and acquired entity of young adults. It is seen more commonly in men than in women, and has an estimated incidence of 26 / 100,000 in the general population.1 PSD begins when hair follicles penetrate into one or more sinus
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walls, mostly in the sacrococcygeal region (although this can occur in several other anatomical locations), followed by development of a chronic infection, either acute or subacute.1,2 The main principles in the surgical treatment of PSD are to minimize the amount
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of postoperative pain and wound care needed, to minimize the recurrence rate, and to enable the patient to return to daily life as soon as possible. To date, many options for surgical
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treatment of the disease have been developed and described, but there is yet no consensus about treatment, as all the surgical methods produce various recurrence rates. Unfortunately, in spite of superiority of the flap transposition techniques over the nonflap techniques, morbidity and recurrence rates have not been completely ruled out.2,3 Asymmetric closure
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techniques are being used in the management of sacrococcygeal PSD, including the modified Limberg flap transposition technique and the lateral advancement flap transposition with Burow's triangle technique. The aim of both techniques is to achieve an off-midline closure of
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the surgical wound after excision of the diseased natal cleft. Several studies have reported that lateralization of the natal cleft is important in preventing midline recurrence.4
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To date, no randomized study has appeared in the literature comparing these specific
techniques. The aim of the present study was to compare the short-term results of modified Limberg flap transposition, a widely used technique in PSD surgical treatment, with lateral advancement flap transposition with Burow's triangle, a relatively less frequently used technique, in terms of Visual Analog Scale (VAS) pain scores, recurrence, postoperative complications, and surgical site infections in the first 12 months postoperatively.
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ACCEPTED MANUSCRIPT METHODS Study Design
This study was planned as a prospective randomized clinical trial. The study subjects were 100 consecutive patients with PSD admitted to Ankara Mevki Military Hospital
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General Surgery Service between May 2013 and August 2013. The study protocol was approved by the Gulhane Military Medical Academy Local Ethics Council (number 001642), and was registered at ClinicalTrials.gov (NCT number 02116738). All patients in the study
participate with the written consent form.
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received detailed preoperative information about the study, and confirmed their willingness to
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Patients were randomly assigned to undergo surgery with either modified Limberg flap transposition or lateral advancement flap transposition with Burow's triangle. Patient information was recorded in the computer, and the patients were randomly divided into two groups. Ten patients were excluded from the study. Exclusion criteria included: age below 15
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years, collagen tissue disease, recurrent generalized PSD, and infection or abscess in relation to PSD. A rhomboid excision and the modified Limberg flap transposition technique was performed in the Group 1 ( n=50). A rectangular sinus excision and the lateral advancement
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flap transposition with Burow's triangle technique was performed in the Group 2 (n=50). All patients underwent surgery in the General Surgery Department of Ankara Mevki Military
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Hospital by the same surgical team. Surgical Technique
Preoperative preparation included bathing the night before surgery. Shaving and
administration of a single intravenous dose of a broad spectrum antibiotic as prophylaxis were performed on the day of surgery. Spinal anesthesia was administered, and the patients were placed in the prone position. The surgical area was disinfected with a 10% povidone-iodine solution.
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In the Group 1, a rhomboid excision and modified Limberg flap boundaries were marked with a marker pen. A rhomboid excision containing the pilonidal sinus tissue was performed, including its ramifications, along with surrounding tissue through the presacral fascia. The cephalic apex remained on the midline and the caudal apex was placed 2 cm
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lateral to the inferior midline, as required by the modified version.5 Then, a fasciocutaneous transposition flap was tailored on the gluteal region contralateral to the asymmetric lower apex of the defect, fully mobilized on its inferior edge, and transposed medially to fill the
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rhomboid defect without tension. Silicone drainage tubes were placed under negative pressure in all of the patients. The subcutaneous tissue was approximated with a layer of interrupted
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Vicryl® 2/0 sutures, and the skin was closed with a skin stapler.
In the Group 2, a rectangular-shaped excision and lateral advancement flap with Burow's triangle boundaries were marked with a marker pen. A rectangular excision containing the diseased tissue was performed, including all sinuses and their ramifications,
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along with surrounding tissue through the presacral fascia. The optimum size of the flap was kept at about 1.5 to 2 times the size of the defect to be closed. The fasciocutaneous rectangular transposition flap contained skin and adipose tissue with its underlying fascia
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except muscle tissue. The flap raised was of uniform thickness until its base. We also performed Burow's triangle technique, which is a technique conducive to performance of the
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lateral advancement flap transposition technique to avoid crossing a nonaesthetic boundary and creating "dog ears," and to conceal an incision line in a less conspicuous location.6 Two Burow's triangles were cut at the corners of the base of the flap for proper approximation. The fasciocutaneous transposition flap with Burow's triangle was transposed laterally to fill the rectangular defect without tension. Silicone drainage tubes were placed under negative pressure in all of the patients. The subcutaneous tissue was approximated with a layer of interrupted Vicryl® 2/0 sutures, and the skin was closed with a skin stapler.
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ACCEPTED MANUSCRIPT Postoperative Period
The patients were mobilized on the 1st postoperative day. The drainage tubes were taken out 48 hours postoperatively when the effluent was less than 20 mL per 24 hours for 2 consecutive days. The senior surgical nurse noted the patients' VAS scores at 0, 6, 12, 24, and
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48 hours after surgery. Then, the mean VAS scores were calculated and recorded. The patients were discharged from the hospital on the 2nd postoperative day if there was no effluent, seroma or hematoma. The sutures were removed on the 14th postoperative day. The
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patients were asked to come for follow-up appointments on the 10 th day especially for SSI, and first, sixth and twelfth month postoperatively. Any clinical changes such as recurrence,
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wound dehiscence, surgical site infection or any other any complication discovered during the follow-up period was compared and recorded. Statistical Analysis
In this study our main outcome measures were early wound dehiscence, recurrence,
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and surgical site infection. All results during the patients' first 12 postoperative months were statistically compared. The sample size and power of the study was calculated with G* Power program (G* Power Ver.3.0.10, Universität Kiel, Germany). A number of minimum 100
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subjects were established for designating error Type I: 0.05, error Type II: 0.20 ratios and determining the differences assumed between the two groups’ width effect (f=0.57) and for
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obtaining 80 % power for the study. One hundred subjects were distributed equally into two groups. The variables of age, body mass index (BMI), duration of complaints, length of operation and their fit to the normal distribution were evaluated by the Shapiro-Wilk test. The median and minimum and maximum values were used to represent the variables determined to have non-Gaussian distribution, as well as the descriptive statistics of discrete variables. The percentage values and number (n) were given for main outcome measures. The main outcome measures, and relationships between groups were also analyzed with Fisher exact
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test. In both groups the other outcome measures; duration of complaints, operative time, length of hospital stay, VAS scores and variables were evaluated by the Mann-Whitney U test. IBM SPSS Statistics for Windows version 21.0 (IBM Corporation, Armonk, NY,
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USA) and MS-Excel 2007 (Microsoft Corporation, Redmond, WA, USA) were used for statistical analysis and calculations. The level of p0.05), (Table 1). The VAS scores were similar between groups (Z=1.590; p=0.112). In the patients who underwent the modified Limberg procedure, the median VAS score was 2 (1-4); the other
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group’s median VAS score was 3 (1-4), (Table 1).
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Wound dehiscence was observed in five patients (5.0%) in the first postoperative week; two (2.0%) of those five patients also had early surgical site infections. Recurrent disease occurred in 1 patient (1.0 %) at six months after surgery (Table 2). Surgical site infection occurred in 2 patients who underwent the modified Limberg
operation (p=0.495). No statistically significant differences were found in wound dehiscence and recurrence, respectively, between the groups (p=0.645; p=1.000), (Table 2).
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ACCEPTED MANUSCRIPT DISCUSSION
There is no consensus on the treatment of PSD, with many debates ongoing regarding the best treatment. A study conducted in Turkey showed that 83% of the surgeons prefer surgical methods in the treatment of PSD.7 The optimal surgical procedures for PSD should
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result in minimal length of hospital stay, satisfactory VAS scores, low disease recurrence, low complication rates, as much aesthetic satisfaction as possible, and allow patients to return quickly to work.8,9
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Complications and recurrence rates seem to be the most important parameters in evaluating the effectiveness of a surgical method for PSD. Analysis of the literature while
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considering these criteria reveals that all of the flap methods provide important advantages, such as low infection and recurrence rates, short hospital stay, and quite favourable aesthetic result.10-12 The most frequently reported disadvantage of the flap methods is the wide angle of the extended incision, bringing about tensed suture lines and less desirable aesthetic
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outcomes.13 Nevertheless, with the flap techniques, the internal cleft's depth, which leads to hair irritation, can be reduced and flattened, and tissue can be approximated without tension.14,15
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Lateral advancement adipo-fasciocutaneous flap transposition with Burow's triangle technique, which has recently begun to be used, is a rectangular flap containing adipose tissue
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with its underlying fascia and overlying skin, and differs from the adipo-fascial turnover flap described by Onishi and Maruyama.16 With the modified Limberg transposition flap technique, which is used more often than the lateral advancement flap technique with Burow's triangle, surgeons perform exactly the same method as with Limberg flap transposition; the only difference is that the bottom edge of the rhomboid incison is lateralized at the modified version to avoid recurrence of PSD.17,18
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Generally, the average operative time of surgery using flap techniques is 40 minutes, ranging from 35–60 minutes in the literature.
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Patients with multiple, recurrent or deeper
sinuses required a little longer operative time. In the present study, the mean operative time for the Group 1 was 42.5 minutes, whereas the mean operative time for the Group 2 was 40.0
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minutes. There was no statistically significant difference in operative time between the groups (p=0.175), (Table 1).
Another important criterion that displays the success and effectiveness of a surgical
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technique is the length of hospital stay. In particular, the morbidity of a surgical technique is demonstrated by the length of hospital stay and time required to return to work.19,20,21 In the
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present study, the mean length of hospital stay was 2 days in the Group 1, and 3 days in the Group 2. There was no statistically significant difference in the length of hospital stay between the groups (p=0.515), and these results correlated with the literature (Table 1).13,22
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The "Achilles’ heel" for treatment of PDS is early or late recurrence, and, precisely on this issue, all of the flap techniques seem to be in the strongest position. While many of the flap techniques reported in the literature have early or late recurrence rates that vary from 0–5
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%, there is no result more satisfactory than that produced by the lateral advancement flap with Burow's triangle technique or modified Limberg technique, both with respect to early and late
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recurrence.23,24 In the present study, when the two surgical methods were compared for minor complications, similar rates were observed. In the present study, the mean follow-up period for all cases was 12 months; recurrence was observed in one patient who was in Group 1 (1%) in the 6th postoperative month. We operated on him a second time with the same technique. There was no recurrence in Group 2 during the follow-up period. There was no statistically significant difference in the recurrence rates between the two groups in the present study (Table 2).
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Regarding the surgical treatment of PSD, the literature especially discusses another main complication: wound dehiscence.
12,25
In the present study, there were five occurrences
of minimal wound dehiscence. Three (6%) of them were in Group 1 and two (4%) of them were in Group 2. This complication occurred due to surgical site infection in two patients in
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Group 1. These two cases resolved by second intention and with antibiotic therapy. The other patients healed by second intention without requiring additional procedures. There was no statistically significant difference in the wound dehiscence rates between the two groups in
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the present study (p=0.645), (Table 2).
When considering the literature with respect to pain or the VAS, there are many
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controversial data about postoperative pain in connection with the flap techniques.26,27 According to our clinical experience, we also believe that the flap technique is more effective in terms of postoperative pain compared with other techniques. In the present study, the VAS scores were similar and quite moderate for a flap procedure in both groups. There was no
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statistically significant difference in VAS scores between the groups (p=0.112), (Table 1). Lateral advancement flap transposition with Burow's triangle was planned to improve the flap technique for PSD. This flap technique subsequently became our other choice besides
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the modified Limberg flap technique for closure of wounds of any size because it gave encouraging results, was technically easy, had a highly satisfactory operative time, was
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cosmetically more acceptable, and had no recurrence.28 From our experience within the scope of the technical implementation of this relatively new procedure and with the limited amount of data on the procedure in the literature, we recommend using the lateral advancement flap technique for upper segment lesions because there may occur substantial height differences, while closing the defect, on lesions close to the anus. The modified Limberg flap transposition technique appears to provide a more effective flattening of the natal cleft, especially in cases in which the inferior part is inclined to invert toward the anal region. Beside our clinical
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experiences, all of the results with both procedures were very similar in our study and because it has not been supported with sound data yet, it can be only a clinical proposal without conflict of interest. A limitation of the present study were the lack of a questionnaire about patient
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aesthetic satisfaction and the small sample size. One of the reasons that we did not take the patient aesthetic satisfaction issue into consideration is that we did not think there would be a difference between the two groups who underwent the two particular procedures in this study.
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Because neither technique was a "minimally invasive technique," they resulted in roughly the same surgical scars in the postoperative period. Another limitation which is the small sample
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size also caused to be little indication that we expected to find a difference between procedures. Nevertheless, further studies that include a questionnaire about aesthetic satisfaction or have larger sample size which would allow authors to report similar findings between procedures within the context, may be useful.
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Conclusion
In conclusion, all of the flap techniques have some advantages or disadvantages. The results of the present study did not reveal a statistically significant difference between the two
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flap techniques in terms of recurrence rate, VAS pain scores, length of hospital stay, wound dehiscence, surgical site infection, or mean operative time. In addition, beside our clinical
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experiences, we found approximate equivalence in both procedures. On this subject, further randomized controlled studies with a large number of patients and longer follow-up period are needed for formal equivalance testing.
Acknowledgments The authors thank Marilyn Carlson for her editorial assistance.
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ACCEPTED MANUSCRIPT REFERENCES
1. Harlak A, Mentes O, Kilic S, Coskun K, Duman K, Yilmaz F. Sacrococcygeal pilonidal disease: analysis of previously proposed risk factors. Clinics (Sao Paulo). 2010;65:125–131. 2. Arumugam PJ, Chandrasekaran TV, Morgan AR, Beynon J, Carr ND. The rhomboid flap for
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pilonidal disease. Colorectal Dis. 2003;5:218–221. 3. Yilmaz S, Kirimlioglu V, Katz D. Role of simple V-Y advancement flap in the treatment of complicated pilonidal sinus. Eur J Surg. 2000;166:269–272.
for pilonidal sinus. Dis Colon Rectum. 2007;50:1436–1444.
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4. Unalp HR, Derici H, Kamer E, Nazli O, Onal MA. Lower recurrence rate for Limberg vs. V-Y flap
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5. Menteş B, Leventoğlu S, Cihan A, Tatlicioglu E, Akin M, Oguz M. Modified Limberg transposition flap for sacrococcygeal pilonidal sinus. Surg Today. 2004;34:419–423.
6. Gormley DE. A brief analysis of the Burow's wedge/triangle principle. J Dermatol Surg Oncol. 1985;11:121–123.
7. Çolak T, Sücüllü İ, Sinan H, Sengül N, Terzi C. Results of surgeon attitude questionnaire on
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pilonidal sinus. Kolon Rektum Hast Derg. 2011;21:165–172.
8. Koorista HP. Pilonidal sinuses. Review of literature and report of three hundred and fifty cases. Am J Surg. 1942;55:3–17.
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9. Akıncı OF, Coskun A, Uzunköy A. Simple and effective surgical treatment of pilonidal sinus: asymmetric excision and primary closure using suction drain and subcuticular skin closure. Dis Colon
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Rectum. 2000;43:701–707.
10. Kapan M, Kapan S, Pekmezci S, Durgun V. Sacrococcygeal pilonidal sinus disease with Limberg flap repair. Tech Coloproctol. 2002;6:27–32. 11. Bozkurt MK, Tezel E. Management of pilonidal sinus with the Limberg flap. Dis Colon Rectum. 1998;41:775–777. 12. Mentes O, Bagci M, Bilgin T, Coskun I, Ozgul O, Ozdemir M. Management of pilonidal sinus disease with oblique excision and primary closure: results of 493 patients. Dis Colon Rectum. 2006;49:104–108.
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13. Eryilmaz R, Sahin M, Alimoglu O, Dasiran F. Surgical treatment of sacrococcygeal pilonidal sinus with the Limberg transposition flap. Surgery. 2003;134:745–749. 14. Schoeller T, Wechselberger G, Otto A, Papp C. Definite surgical treatment of complicated recurrent pilonidal disease with a modified fasciocutaneous V-Y advancement flap. Surgery.
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1997;121:258–263. 15. Manterola C, Barroso M, Araya JC, Fonseca L. Pilonidal disease: 25 cases treated by the Dufourmental technique. Dis Colon Rectum. 1991;34:649–652.
sinus. Plast Reconstr Surg. 2001;108:2006–2010.
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16. Onishi K, Maruyama Y. Sacral adipofascial turn-over flap for the excisional defect of pilonidal
17. Akin M, Leventoglu S, Mentes BB, et al. Comparison of the classic Limberg flap and modified
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Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010;40:757–762.
18. Cihan A, Ucan BH, Comert M, Cesur A, Cakmak GK, Tascilar O. Superiority of asymmetric modified Limberg flap for surgical treatment of pilonidal disease. Dis Colon Rectum. 2006;49:244–
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19. Raghubir S, Pavithran NM. Adipo-fascio-cutaneous flaps in the treatment of pilonidal sinus: experience with 50 cases. Asian J Surg. 2005;28:198–201.
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20. Leventoglu S, Ozdemir S, Ozgay N, et al. Comparison of primary closure with Limberg flap in the treatment of pilonidal disease. Kolon Rektum Hast Derg. 2008;19:90–92.
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21. Rossi P, Rusoo F, Gentileschi P, et al. [The pilonidal sinus: its surgical management, our experience and a review of the literature]. G Chir. 1993;14:120–123. [Article in Italian.] 22. Abu Galala KH, Salam IM, Abu Samaan KR, et al. Treatment of pilonidal sinus by primary closure with a transposed rhomboid flap compared with deep suturing: a prospective randomized clinical trial. Eur J Surg. 1999;165:468–472. 23. Urhan MK, Kücükel F, Topgul K, Ozer I, Sari S. Rhomboid excision and Limberg flap for managing pilonidal sinus: results of 102 cases. Dis Colon Rectum. 2002;45:656–659. 24. Mansoory A, Dickson D. Z-plasty for treatment of disease of the pilonidal sinus. Surg Gynecol Obstet. 1982;155:409–411.
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25. Ertan T, Koc M, Gocmen E, Aslar AK, Keskek M, Lilic M. Does technique alter quality of life after pilonidal sinus surgery? Am J Surg. 2005;190:388–392. 26. Muzi MG, Milito G, Cadeddu F, et al. Randomized comparison of Limberg flap versus modified primary closure for the treatment of pilonidal disease. Am J Surg. 2010;200:9–14.
excision. Dis Colon Rectum. 2008;51:1816–1822.
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27. Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after
28. Boggio P, Gattoni M, Zanetta R, Leigheb G. Burow's triangle advancement flaps for excision of
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two closely approximated skin lesions. Dermatol Surg. 1999;25:622–625.
ACCEPTED MANUSCRIPT Table 1.The overall demographics and by the groups Overall
Group
Median (min; max) 23 (19; 34)
Age (years)
Test statistics
Group 1: modified Limberg
Group 2: lateral advancement
Median (min; max)
Median (min; max)
z
p
23 (20; 34)
23 (19; 31)
0.302
0.763
24.9 (20.0; 36.0)
24.7 (21.0; 29.0)
25.2 (20.0; 36.0)
1.159
0.247
Operative time (min) Hospital stay (days)
40.0 (35.0; 90.0)
42.5 ( 35.0; 55.0)
40.0 (35.0; 90.0)
1.357
0.175
2.5 (2.0; 8.0)
2.0 (2.0; 5.0)
3.0 (2.0; 8.0)
0.651
0.515
2 (1; 4)
2 (1; 4)
3 (1; 4)
1.590
0.112
VAS** score
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2
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BMI * (kg/m )
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* : Body Mass Index; **: Visual Analog Scale
Table 2. Comparison of the overall outcomes and by the groups* Overall
n (%)
Surgical site infection Positive Positive Recurrence Positive
2 (4.0)
0 (0.0)
0,495**
5 (5.0)
3 (6.0)
2 (4.0)
1.000 **
1 (2.0)
0 (0.0)
1,000 **
1 (1.0)
* : Column percentage is given **: Fisher exact test result ( Two cells (50.0%) have expected count less than 5. The minimum expected count is 1.00, 2.50 and 0.50, respectively)
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p
2 (2.0)
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Wound dehiscence
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Variables
Group Group 1: modified Group 2: lateral Limberg advancement n (%) n (%)
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CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic
Item No Checklist item
Reported on page No
1a
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Title and abstract Identification as a randomised trial in the title
1 3-4
Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
2a 2b
Scientific background and explanation of rationale Specific objectives or hypotheses
Interventions
3a 3b 4a 4b 5
6 6 6 5-8 6-7-8
Outcomes
6a
Sample size
6b 7a 7b
Description of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), with reasons Eligibility criteria for participants Settings and locations where the data were collected The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Any changes to trial outcomes after the trial commenced, with reasons How sample size was determined When applicable, explanation of any interim analyses and stopping guidelines
8a 8b 9
Method used to generate the random allocation sequence Type of randomisation; details of any restriction (such as blocking and block size) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
6 _ 7-8
10
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
7-8
Randomisation: Sequence generation Allocation concealment mechanism Implementation
CONSORT 2010 checklist
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Participants
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Methods Trial design
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Introduction Background and objectives
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1b
5 5
8 _ _ 8-9
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11a
Statistical methods
11b 12a 12b
Results Participant flow (a diagram is strongly recommended) Recruitment
Harms
19
Discussion Limitations Generalisability Interpretation
20 21 22
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability (external validity, applicability) of the trial findings Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
Other information Registration Protocol Funding
23 24 25
Registration number and name of trial registry Where the full trial protocol can be accessed, if available Sources of funding and other support (such as supply of drugs), role of funders
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17a
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Outcomes and estimation
13b 14a 14b 15 16
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Ancillary analyses
17b 18
For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, losses and exclusions after randomisation, together with reasons Dates defining the periods of recruitment and follow-up Why the trial ended or was stopped A table showing baseline demographic and clinical characteristics for each group For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Baseline data Numbers analysed
13a
If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how If relevant, description of the similarity of interventions Statistical methods used to compare groups for primary and secondary outcomes Methods for additional analyses, such as subgroup analyses and adjusted analyses
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Blinding
_ 7-8 8-9 8-9 9 _ 9 _ Table-1 Table-3 Table-3 _ Table 2-4 _ 12-13-14 10-11-12-13 10-11-12-13 6 6 _
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. CONSORT 2010 checklist
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Enrollment
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Assessed for eligibility (n= 110 )
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CONSORT 2010 Flow Diagram
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Excluded (n=10 ) ♦ Not meeting inclusion criteria (n=10 ) ♦ Declined to participate (n= 0 ) ♦ Other reasons (n= 0 )
Randomized (n= 100 )
Allocation
Allocated to intervention (n=50) ♦ Received allocated intervention (n=50)
♦
♦
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Allocated to intervention (n=50 ) ♦ Received allocated intervention (n=50)
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Lost to follow-up (n=0)
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Did not receive allocated intervention (n=0)
Follow-Up Lost to follow-up (n= 0 )
Discontinued intervention (n=0)
Analysed (n=50) ♦ Excluded from analysis (n=0)
Did not receive allocated intervention (n=0)
Discontinued intervention (n=0 )
Analysis Analysed (n=50 ) ♦ Excluded from analysis (n=0)
S0002-9610(15)00331-1
DOI:
10.1016/j.amjsurg.2015.03.031
Reference:
AJS 11557
To appear in:
The American Journal of Surgery
Received Date: 2 October 2014 Revised Date:
20 March 2015
Accepted Date: 30 March 2015
Please cite this article as: Saydam M, Ozturk B, Sinan H, Balta AZ, Demir P, Ozer MT, Demirbas S, Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burow's Triangle in the Treatment of Pilonidal Sinus Disease, The American Journal of Surgery (2015), doi: 10.1016/j.amjsurg.2015.03.031. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Word count for the abstract: 299 STRUCTURED ABSTRACT
Background: Although many options exist for surgical treatment of pilonidal sinus
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disease (PSD), consensus has not yet been achieved, as all surgical methods have various rates of complications, postoperative infection, and recurrence.
Objective: This study compared two surgical treatments for PSD: modified Limberg
Design: Prospective, randomized, clinical trial.
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flap transposition and lateral advancement flap transposition with Burow's triangle.
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Setting: Ankara Mevki Military Hospital General Surgery Service
Patients: Consecutive 100 patients admitted to hospital for treatment of PSD from May 2013 to August 2013.
Interventions: The patients received surgical treatment with either modified Limberg
triangle (n=50).
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flap transposition (n=50) or lateral advancement flap transposition with Burow’s
Main Outcome Measures: Clinical healing period; length of hospital stay; operative
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time; postoperative complications including recurrence, wound dehiscence, surgical site infection, as noted during postoperative follow-up period; Visual Analog Scale
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(VAS) scores for pain.
Results: The mean follow-up period was 12 months. No significant differences were observed between the two groups in length of hospital stay (p=0.515), operative time (p=0.175), wound dehiscence (p=0.645), and VAS pain scores (p=0.112). The mean operative times were 42.5 minutes in the modified Limberg group and 40.0 minutes in the lateral advancement group. Limitations: No questionnaire was offered to the patients about their postoperative aesthetic satisfaction. A further study on this aspect may be useful.
ACCEPTED MANUSCRIPT Conclusions: Although lateral advancement flap transposition with Burow's triangle is used less often than modified Limberg flap transposition, we could not determine a parameter that was statistically different such as operative time, postoperative complication or the length of hospital stay. Hence, the lateral advancement flap is as
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viable an option as other more preferable techniques in the treatment of PSD which particularly settled on the upper segment without a deep natal cleft.
Keywords: Pilonidal sinus disease; Lateral advancement; modified Limberg; Burow; Surgical
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treatment.
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Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burow's Triangle in the Treatment of Pilonidal Sinus Disease
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Conflicts of interest: None
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Financial support: None
Authors List:
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1-Mehmet SAYDAM, M.D., (The Corresponding Author)
Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100 TURKEY
Email:msaydam@2008 hotmail.com Tel:+905344535319 Fax:+903123113535
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2-Bulent OZTURK, M.D., (Contribution of Acquisition of Data)
Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100 TURKEY
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3-Huseyin SINAN, Associate Professor M.D., (Contribution of Conseption and Design) Ankara Mevki Military Hospital Department of General Surgery, Dıskapı, ANKARA, 061100
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TURKEY
4-Ahmet Z. BALTA, M.D., (Contribution of Conseption and Design) Istanbul Gulhane Haydarpasa Medical Training Hospital, Deparment of General Surgery Istanbul, 34668, TURKEY 5-Pervin Demir, Research Assistant, (Contribution of Drafting The Article) Yıldırım Beyazıt University, Department of Medical Biostatistics , Dıskapı, 061100, Ankara, TURKEY
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6-Mustafa T. OZER, Associate Professor, (Contribution of Revising The Manuscipt Critically) Gulhane Military Medical Academy, Department of General Surgery, Etlik, 06100, Ankara, TURKEY
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7-Sezai DEMIRBAS, Professor, (Contribution of Approval of The Manuscript)
Gulhane Military Medical Academy, Department of General Surgery, Etlik, 06100, Ankara, TURKEY
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Word count for the manuscript: 2694
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ACCEPTED MANUSCRIPT INTRODUCTION
Pilonidal Sinus Disease (PSD) is a common and acquired entity of young adults. It is seen more commonly in men than in women, and has an estimated incidence of 26 / 100,000 in the general population.1 PSD begins when hair follicles penetrate into one or more sinus
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walls, mostly in the sacrococcygeal region (although this can occur in several other anatomical locations), followed by development of a chronic infection, either acute or subacute.1,2 The main principles in the surgical treatment of PSD are to minimize the amount
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of postoperative pain and wound care needed, to minimize the recurrence rate, and to enable the patient to return to daily life as soon as possible. To date, many options for surgical
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treatment of the disease have been developed and described, but there is yet no consensus about treatment, as all the surgical methods produce various recurrence rates. Unfortunately, in spite of superiority of the flap transposition techniques over the nonflap techniques, morbidity and recurrence rates have not been completely ruled out.2,3 Asymmetric closure
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techniques are being used in the management of sacrococcygeal PSD, including the modified Limberg flap transposition technique and the lateral advancement flap transposition with Burow's triangle technique. The aim of both techniques is to achieve an off-midline closure of
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the surgical wound after excision of the diseased natal cleft. Several studies have reported that lateralization of the natal cleft is important in preventing midline recurrence.4
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To date, no randomized study has appeared in the literature comparing these specific
techniques. The aim of the present study was to compare the short-term results of modified Limberg flap transposition, a widely used technique in PSD surgical treatment, with lateral advancement flap transposition with Burow's triangle, a relatively less frequently used technique, in terms of Visual Analog Scale (VAS) pain scores, recurrence, postoperative complications, and surgical site infections in the first 12 months postoperatively.
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ACCEPTED MANUSCRIPT METHODS Study Design
This study was planned as a prospective randomized clinical trial. The study subjects were 100 consecutive patients with PSD admitted to Ankara Mevki Military Hospital
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General Surgery Service between May 2013 and August 2013. The study protocol was approved by the Gulhane Military Medical Academy Local Ethics Council (number 001642), and was registered at ClinicalTrials.gov (NCT number 02116738). All patients in the study
participate with the written consent form.
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received detailed preoperative information about the study, and confirmed their willingness to
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Patients were randomly assigned to undergo surgery with either modified Limberg flap transposition or lateral advancement flap transposition with Burow's triangle. Patient information was recorded in the computer, and the patients were randomly divided into two groups. Ten patients were excluded from the study. Exclusion criteria included: age below 15
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years, collagen tissue disease, recurrent generalized PSD, and infection or abscess in relation to PSD. A rhomboid excision and the modified Limberg flap transposition technique was performed in the Group 1 ( n=50). A rectangular sinus excision and the lateral advancement
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flap transposition with Burow's triangle technique was performed in the Group 2 (n=50). All patients underwent surgery in the General Surgery Department of Ankara Mevki Military
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Hospital by the same surgical team. Surgical Technique
Preoperative preparation included bathing the night before surgery. Shaving and
administration of a single intravenous dose of a broad spectrum antibiotic as prophylaxis were performed on the day of surgery. Spinal anesthesia was administered, and the patients were placed in the prone position. The surgical area was disinfected with a 10% povidone-iodine solution.
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In the Group 1, a rhomboid excision and modified Limberg flap boundaries were marked with a marker pen. A rhomboid excision containing the pilonidal sinus tissue was performed, including its ramifications, along with surrounding tissue through the presacral fascia. The cephalic apex remained on the midline and the caudal apex was placed 2 cm
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lateral to the inferior midline, as required by the modified version.5 Then, a fasciocutaneous transposition flap was tailored on the gluteal region contralateral to the asymmetric lower apex of the defect, fully mobilized on its inferior edge, and transposed medially to fill the
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rhomboid defect without tension. Silicone drainage tubes were placed under negative pressure in all of the patients. The subcutaneous tissue was approximated with a layer of interrupted
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Vicryl® 2/0 sutures, and the skin was closed with a skin stapler.
In the Group 2, a rectangular-shaped excision and lateral advancement flap with Burow's triangle boundaries were marked with a marker pen. A rectangular excision containing the diseased tissue was performed, including all sinuses and their ramifications,
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along with surrounding tissue through the presacral fascia. The optimum size of the flap was kept at about 1.5 to 2 times the size of the defect to be closed. The fasciocutaneous rectangular transposition flap contained skin and adipose tissue with its underlying fascia
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except muscle tissue. The flap raised was of uniform thickness until its base. We also performed Burow's triangle technique, which is a technique conducive to performance of the
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lateral advancement flap transposition technique to avoid crossing a nonaesthetic boundary and creating "dog ears," and to conceal an incision line in a less conspicuous location.6 Two Burow's triangles were cut at the corners of the base of the flap for proper approximation. The fasciocutaneous transposition flap with Burow's triangle was transposed laterally to fill the rectangular defect without tension. Silicone drainage tubes were placed under negative pressure in all of the patients. The subcutaneous tissue was approximated with a layer of interrupted Vicryl® 2/0 sutures, and the skin was closed with a skin stapler.
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ACCEPTED MANUSCRIPT Postoperative Period
The patients were mobilized on the 1st postoperative day. The drainage tubes were taken out 48 hours postoperatively when the effluent was less than 20 mL per 24 hours for 2 consecutive days. The senior surgical nurse noted the patients' VAS scores at 0, 6, 12, 24, and
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48 hours after surgery. Then, the mean VAS scores were calculated and recorded. The patients were discharged from the hospital on the 2nd postoperative day if there was no effluent, seroma or hematoma. The sutures were removed on the 14th postoperative day. The
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patients were asked to come for follow-up appointments on the 10 th day especially for SSI, and first, sixth and twelfth month postoperatively. Any clinical changes such as recurrence,
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wound dehiscence, surgical site infection or any other any complication discovered during the follow-up period was compared and recorded. Statistical Analysis
In this study our main outcome measures were early wound dehiscence, recurrence,
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and surgical site infection. All results during the patients' first 12 postoperative months were statistically compared. The sample size and power of the study was calculated with G* Power program (G* Power Ver.3.0.10, Universität Kiel, Germany). A number of minimum 100
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subjects were established for designating error Type I: 0.05, error Type II: 0.20 ratios and determining the differences assumed between the two groups’ width effect (f=0.57) and for
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obtaining 80 % power for the study. One hundred subjects were distributed equally into two groups. The variables of age, body mass index (BMI), duration of complaints, length of operation and their fit to the normal distribution were evaluated by the Shapiro-Wilk test. The median and minimum and maximum values were used to represent the variables determined to have non-Gaussian distribution, as well as the descriptive statistics of discrete variables. The percentage values and number (n) were given for main outcome measures. The main outcome measures, and relationships between groups were also analyzed with Fisher exact
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test. In both groups the other outcome measures; duration of complaints, operative time, length of hospital stay, VAS scores and variables were evaluated by the Mann-Whitney U test. IBM SPSS Statistics for Windows version 21.0 (IBM Corporation, Armonk, NY,
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USA) and MS-Excel 2007 (Microsoft Corporation, Redmond, WA, USA) were used for statistical analysis and calculations. The level of p0.05), (Table 1). The VAS scores were similar between groups (Z=1.590; p=0.112). In the patients who underwent the modified Limberg procedure, the median VAS score was 2 (1-4); the other
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group’s median VAS score was 3 (1-4), (Table 1).
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Wound dehiscence was observed in five patients (5.0%) in the first postoperative week; two (2.0%) of those five patients also had early surgical site infections. Recurrent disease occurred in 1 patient (1.0 %) at six months after surgery (Table 2). Surgical site infection occurred in 2 patients who underwent the modified Limberg
operation (p=0.495). No statistically significant differences were found in wound dehiscence and recurrence, respectively, between the groups (p=0.645; p=1.000), (Table 2).
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ACCEPTED MANUSCRIPT DISCUSSION
There is no consensus on the treatment of PSD, with many debates ongoing regarding the best treatment. A study conducted in Turkey showed that 83% of the surgeons prefer surgical methods in the treatment of PSD.7 The optimal surgical procedures for PSD should
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result in minimal length of hospital stay, satisfactory VAS scores, low disease recurrence, low complication rates, as much aesthetic satisfaction as possible, and allow patients to return quickly to work.8,9
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Complications and recurrence rates seem to be the most important parameters in evaluating the effectiveness of a surgical method for PSD. Analysis of the literature while
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considering these criteria reveals that all of the flap methods provide important advantages, such as low infection and recurrence rates, short hospital stay, and quite favourable aesthetic result.10-12 The most frequently reported disadvantage of the flap methods is the wide angle of the extended incision, bringing about tensed suture lines and less desirable aesthetic
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outcomes.13 Nevertheless, with the flap techniques, the internal cleft's depth, which leads to hair irritation, can be reduced and flattened, and tissue can be approximated without tension.14,15
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Lateral advancement adipo-fasciocutaneous flap transposition with Burow's triangle technique, which has recently begun to be used, is a rectangular flap containing adipose tissue
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with its underlying fascia and overlying skin, and differs from the adipo-fascial turnover flap described by Onishi and Maruyama.16 With the modified Limberg transposition flap technique, which is used more often than the lateral advancement flap technique with Burow's triangle, surgeons perform exactly the same method as with Limberg flap transposition; the only difference is that the bottom edge of the rhomboid incison is lateralized at the modified version to avoid recurrence of PSD.17,18
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Generally, the average operative time of surgery using flap techniques is 40 minutes, ranging from 35–60 minutes in the literature.
19
Patients with multiple, recurrent or deeper
sinuses required a little longer operative time. In the present study, the mean operative time for the Group 1 was 42.5 minutes, whereas the mean operative time for the Group 2 was 40.0
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minutes. There was no statistically significant difference in operative time between the groups (p=0.175), (Table 1).
Another important criterion that displays the success and effectiveness of a surgical
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technique is the length of hospital stay. In particular, the morbidity of a surgical technique is demonstrated by the length of hospital stay and time required to return to work.19,20,21 In the
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present study, the mean length of hospital stay was 2 days in the Group 1, and 3 days in the Group 2. There was no statistically significant difference in the length of hospital stay between the groups (p=0.515), and these results correlated with the literature (Table 1).13,22
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The "Achilles’ heel" for treatment of PDS is early or late recurrence, and, precisely on this issue, all of the flap techniques seem to be in the strongest position. While many of the flap techniques reported in the literature have early or late recurrence rates that vary from 0–5
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%, there is no result more satisfactory than that produced by the lateral advancement flap with Burow's triangle technique or modified Limberg technique, both with respect to early and late
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recurrence.23,24 In the present study, when the two surgical methods were compared for minor complications, similar rates were observed. In the present study, the mean follow-up period for all cases was 12 months; recurrence was observed in one patient who was in Group 1 (1%) in the 6th postoperative month. We operated on him a second time with the same technique. There was no recurrence in Group 2 during the follow-up period. There was no statistically significant difference in the recurrence rates between the two groups in the present study (Table 2).
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Regarding the surgical treatment of PSD, the literature especially discusses another main complication: wound dehiscence.
12,25
In the present study, there were five occurrences
of minimal wound dehiscence. Three (6%) of them were in Group 1 and two (4%) of them were in Group 2. This complication occurred due to surgical site infection in two patients in
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Group 1. These two cases resolved by second intention and with antibiotic therapy. The other patients healed by second intention without requiring additional procedures. There was no statistically significant difference in the wound dehiscence rates between the two groups in
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the present study (p=0.645), (Table 2).
When considering the literature with respect to pain or the VAS, there are many
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controversial data about postoperative pain in connection with the flap techniques.26,27 According to our clinical experience, we also believe that the flap technique is more effective in terms of postoperative pain compared with other techniques. In the present study, the VAS scores were similar and quite moderate for a flap procedure in both groups. There was no
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statistically significant difference in VAS scores between the groups (p=0.112), (Table 1). Lateral advancement flap transposition with Burow's triangle was planned to improve the flap technique for PSD. This flap technique subsequently became our other choice besides
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the modified Limberg flap technique for closure of wounds of any size because it gave encouraging results, was technically easy, had a highly satisfactory operative time, was
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cosmetically more acceptable, and had no recurrence.28 From our experience within the scope of the technical implementation of this relatively new procedure and with the limited amount of data on the procedure in the literature, we recommend using the lateral advancement flap technique for upper segment lesions because there may occur substantial height differences, while closing the defect, on lesions close to the anus. The modified Limberg flap transposition technique appears to provide a more effective flattening of the natal cleft, especially in cases in which the inferior part is inclined to invert toward the anal region. Beside our clinical
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experiences, all of the results with both procedures were very similar in our study and because it has not been supported with sound data yet, it can be only a clinical proposal without conflict of interest. A limitation of the present study were the lack of a questionnaire about patient
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aesthetic satisfaction and the small sample size. One of the reasons that we did not take the patient aesthetic satisfaction issue into consideration is that we did not think there would be a difference between the two groups who underwent the two particular procedures in this study.
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Because neither technique was a "minimally invasive technique," they resulted in roughly the same surgical scars in the postoperative period. Another limitation which is the small sample
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size also caused to be little indication that we expected to find a difference between procedures. Nevertheless, further studies that include a questionnaire about aesthetic satisfaction or have larger sample size which would allow authors to report similar findings between procedures within the context, may be useful.
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Conclusion
In conclusion, all of the flap techniques have some advantages or disadvantages. The results of the present study did not reveal a statistically significant difference between the two
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flap techniques in terms of recurrence rate, VAS pain scores, length of hospital stay, wound dehiscence, surgical site infection, or mean operative time. In addition, beside our clinical
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experiences, we found approximate equivalence in both procedures. On this subject, further randomized controlled studies with a large number of patients and longer follow-up period are needed for formal equivalance testing.
Acknowledgments The authors thank Marilyn Carlson for her editorial assistance.
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1. Harlak A, Mentes O, Kilic S, Coskun K, Duman K, Yilmaz F. Sacrococcygeal pilonidal disease: analysis of previously proposed risk factors. Clinics (Sao Paulo). 2010;65:125–131. 2. Arumugam PJ, Chandrasekaran TV, Morgan AR, Beynon J, Carr ND. The rhomboid flap for
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pilonidal disease. Colorectal Dis. 2003;5:218–221. 3. Yilmaz S, Kirimlioglu V, Katz D. Role of simple V-Y advancement flap in the treatment of complicated pilonidal sinus. Eur J Surg. 2000;166:269–272.
for pilonidal sinus. Dis Colon Rectum. 2007;50:1436–1444.
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4. Unalp HR, Derici H, Kamer E, Nazli O, Onal MA. Lower recurrence rate for Limberg vs. V-Y flap
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5. Menteş B, Leventoğlu S, Cihan A, Tatlicioglu E, Akin M, Oguz M. Modified Limberg transposition flap for sacrococcygeal pilonidal sinus. Surg Today. 2004;34:419–423.
6. Gormley DE. A brief analysis of the Burow's wedge/triangle principle. J Dermatol Surg Oncol. 1985;11:121–123.
7. Çolak T, Sücüllü İ, Sinan H, Sengül N, Terzi C. Results of surgeon attitude questionnaire on
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pilonidal sinus. Kolon Rektum Hast Derg. 2011;21:165–172.
8. Koorista HP. Pilonidal sinuses. Review of literature and report of three hundred and fifty cases. Am J Surg. 1942;55:3–17.
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9. Akıncı OF, Coskun A, Uzunköy A. Simple and effective surgical treatment of pilonidal sinus: asymmetric excision and primary closure using suction drain and subcuticular skin closure. Dis Colon
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Rectum. 2000;43:701–707.
10. Kapan M, Kapan S, Pekmezci S, Durgun V. Sacrococcygeal pilonidal sinus disease with Limberg flap repair. Tech Coloproctol. 2002;6:27–32. 11. Bozkurt MK, Tezel E. Management of pilonidal sinus with the Limberg flap. Dis Colon Rectum. 1998;41:775–777. 12. Mentes O, Bagci M, Bilgin T, Coskun I, Ozgul O, Ozdemir M. Management of pilonidal sinus disease with oblique excision and primary closure: results of 493 patients. Dis Colon Rectum. 2006;49:104–108.
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13. Eryilmaz R, Sahin M, Alimoglu O, Dasiran F. Surgical treatment of sacrococcygeal pilonidal sinus with the Limberg transposition flap. Surgery. 2003;134:745–749. 14. Schoeller T, Wechselberger G, Otto A, Papp C. Definite surgical treatment of complicated recurrent pilonidal disease with a modified fasciocutaneous V-Y advancement flap. Surgery.
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1997;121:258–263. 15. Manterola C, Barroso M, Araya JC, Fonseca L. Pilonidal disease: 25 cases treated by the Dufourmental technique. Dis Colon Rectum. 1991;34:649–652.
sinus. Plast Reconstr Surg. 2001;108:2006–2010.
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16. Onishi K, Maruyama Y. Sacral adipofascial turn-over flap for the excisional defect of pilonidal
17. Akin M, Leventoglu S, Mentes BB, et al. Comparison of the classic Limberg flap and modified
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Limberg flap in the treatment of pilonidal sinus disease: a retrospective analysis of 416 patients. Surg Today. 2010;40:757–762.
18. Cihan A, Ucan BH, Comert M, Cesur A, Cakmak GK, Tascilar O. Superiority of asymmetric modified Limberg flap for surgical treatment of pilonidal disease. Dis Colon Rectum. 2006;49:244–
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19. Raghubir S, Pavithran NM. Adipo-fascio-cutaneous flaps in the treatment of pilonidal sinus: experience with 50 cases. Asian J Surg. 2005;28:198–201.
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20. Leventoglu S, Ozdemir S, Ozgay N, et al. Comparison of primary closure with Limberg flap in the treatment of pilonidal disease. Kolon Rektum Hast Derg. 2008;19:90–92.
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21. Rossi P, Rusoo F, Gentileschi P, et al. [The pilonidal sinus: its surgical management, our experience and a review of the literature]. G Chir. 1993;14:120–123. [Article in Italian.] 22. Abu Galala KH, Salam IM, Abu Samaan KR, et al. Treatment of pilonidal sinus by primary closure with a transposed rhomboid flap compared with deep suturing: a prospective randomized clinical trial. Eur J Surg. 1999;165:468–472. 23. Urhan MK, Kücükel F, Topgul K, Ozer I, Sari S. Rhomboid excision and Limberg flap for managing pilonidal sinus: results of 102 cases. Dis Colon Rectum. 2002;45:656–659. 24. Mansoory A, Dickson D. Z-plasty for treatment of disease of the pilonidal sinus. Surg Gynecol Obstet. 1982;155:409–411.
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25. Ertan T, Koc M, Gocmen E, Aslar AK, Keskek M, Lilic M. Does technique alter quality of life after pilonidal sinus surgery? Am J Surg. 2005;190:388–392. 26. Muzi MG, Milito G, Cadeddu F, et al. Randomized comparison of Limberg flap versus modified primary closure for the treatment of pilonidal disease. Am J Surg. 2010;200:9–14.
excision. Dis Colon Rectum. 2008;51:1816–1822.
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27. Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after
28. Boggio P, Gattoni M, Zanetta R, Leigheb G. Burow's triangle advancement flaps for excision of
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two closely approximated skin lesions. Dermatol Surg. 1999;25:622–625.
ACCEPTED MANUSCRIPT Table 1.The overall demographics and by the groups Overall
Group
Median (min; max) 23 (19; 34)
Age (years)
Test statistics
Group 1: modified Limberg
Group 2: lateral advancement
Median (min; max)
Median (min; max)
z
p
23 (20; 34)
23 (19; 31)
0.302
0.763
24.9 (20.0; 36.0)
24.7 (21.0; 29.0)
25.2 (20.0; 36.0)
1.159
0.247
Operative time (min) Hospital stay (days)
40.0 (35.0; 90.0)
42.5 ( 35.0; 55.0)
40.0 (35.0; 90.0)
1.357
0.175
2.5 (2.0; 8.0)
2.0 (2.0; 5.0)
3.0 (2.0; 8.0)
0.651
0.515
2 (1; 4)
2 (1; 4)
3 (1; 4)
1.590
0.112
VAS** score
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2
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BMI * (kg/m )
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* : Body Mass Index; **: Visual Analog Scale
Table 2. Comparison of the overall outcomes and by the groups* Overall
n (%)
Surgical site infection Positive Positive Recurrence Positive
2 (4.0)
0 (0.0)
0,495**
5 (5.0)
3 (6.0)
2 (4.0)
1.000 **
1 (2.0)
0 (0.0)
1,000 **
1 (1.0)
* : Column percentage is given **: Fisher exact test result ( Two cells (50.0%) have expected count less than 5. The minimum expected count is 1.00, 2.50 and 0.50, respectively)
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p
2 (2.0)
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Wound dehiscence
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Variables
Group Group 1: modified Group 2: lateral Limberg advancement n (%) n (%)
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CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic
Item No Checklist item
Reported on page No
1a
RI PT
Title and abstract Identification as a randomised trial in the title
1 3-4
Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
2a 2b
Scientific background and explanation of rationale Specific objectives or hypotheses
Interventions
3a 3b 4a 4b 5
6 6 6 5-8 6-7-8
Outcomes
6a
Sample size
6b 7a 7b
Description of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), with reasons Eligibility criteria for participants Settings and locations where the data were collected The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Any changes to trial outcomes after the trial commenced, with reasons How sample size was determined When applicable, explanation of any interim analyses and stopping guidelines
8a 8b 9
Method used to generate the random allocation sequence Type of randomisation; details of any restriction (such as blocking and block size) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
6 _ 7-8
10
Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
7-8
Randomisation: Sequence generation Allocation concealment mechanism Implementation
CONSORT 2010 checklist
M AN U
TE D
Participants
EP
Methods Trial design
AC C
Introduction Background and objectives
SC
1b
5 5
8 _ _ 8-9
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11a
Statistical methods
11b 12a 12b
Results Participant flow (a diagram is strongly recommended) Recruitment
Harms
19
Discussion Limitations Generalisability Interpretation
20 21 22
Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability (external validity, applicability) of the trial findings Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
Other information Registration Protocol Funding
23 24 25
Registration number and name of trial registry Where the full trial protocol can be accessed, if available Sources of funding and other support (such as supply of drugs), role of funders
M AN U
TE D
EP
17a
AC C
Outcomes and estimation
13b 14a 14b 15 16
SC
Ancillary analyses
17b 18
For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, losses and exclusions after randomisation, together with reasons Dates defining the periods of recruitment and follow-up Why the trial ended or was stopped A table showing baseline demographic and clinical characteristics for each group For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Baseline data Numbers analysed
13a
If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how If relevant, description of the similarity of interventions Statistical methods used to compare groups for primary and secondary outcomes Methods for additional analyses, such as subgroup analyses and adjusted analyses
RI PT
Blinding
_ 7-8 8-9 8-9 9 _ 9 _ Table-1 Table-3 Table-3 _ Table 2-4 _ 12-13-14 10-11-12-13 10-11-12-13 6 6 _
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. CONSORT 2010 checklist
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Enrollment
SC
Assessed for eligibility (n= 110 )
RI PT
CONSORT 2010 Flow Diagram
M AN U
Excluded (n=10 ) ♦ Not meeting inclusion criteria (n=10 ) ♦ Declined to participate (n= 0 ) ♦ Other reasons (n= 0 )
Randomized (n= 100 )
Allocation
Allocated to intervention (n=50) ♦ Received allocated intervention (n=50)
♦
♦
TE D
Allocated to intervention (n=50 ) ♦ Received allocated intervention (n=50)
AC C
Lost to follow-up (n=0)
EP
Did not receive allocated intervention (n=0)
Follow-Up Lost to follow-up (n= 0 )
Discontinued intervention (n=0)
Analysed (n=50) ♦ Excluded from analysis (n=0)
Did not receive allocated intervention (n=0)
Discontinued intervention (n=0 )
Analysis Analysed (n=50 ) ♦ Excluded from analysis (n=0)
