j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 8 ( 2 0 1 5 ) 2 6 0 e2 6 6
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Karydakis flap versus excision-only technique in pilonidal disease Amir Keshvari, MD,a Mohammad Reza Keramati, MD,a,* Mohammad Sadegh Fazeli, MD,a Alireza Kazemeini, MD,a Alipasha Meysamie, MD,b and Mohammad Kazem Nouritaromlou, MDa a
Department of Surgery, Imam Khomeini Complex Hospital, Tehran University of Medical Sciences, Tehran, Iran Department of Community and Preventive Medicine, Medical Faculty, Tehran University of Medical Sciences, Tehran, Iran
b
article info
abstract
Article history:
Background: Karydakis flap (K-flap) and excision with healing by secondary intention (EHSI)
Received 28 February 2015
are currently accepted methods for surgical management of sacrococcygeal pilonidal
Received in revised form
disease. This clinical trial study aimed to compare early and late outcomes of these two
4 May 2015
surgical techniques.
Accepted 21 May 2015
Materials and methods: In this controlled, prospective, randomized clinical trial, patients
Available online 28 May 2015
diagnosed with sacrococcygeal pilonidal disease were randomly allocated to two groups. Patients in the first group underwent Karydakis procedure, whereas EHSI was the surgical
Keywords:
management in the second group. The two techniques were compared based on their
Pilonidal sinus
overall time of wound healing, return to work, rate of complications, and recurrence.
Surgical flap
Results: A total of 321 patients including 161 in the K-flap group and 160 in the EHSI group
Wound healing
were included in the study. The median follow-up duration was 49 mo. The mean time of
Recurrence
wound healing (16.44 versus 80.01 d, P < 0.001), return to work (14.44 versus 24.19, P < 0.001), rate of wound complications (18.7% versus 31.2%, P ¼ 0.006), and recurrence (1.2% versus 7.5%, P ¼ 0.005) were all significantly lower in the K-flap group. The mean operation time was significantly shorter in the EHSI group (15.87 versus 55.17 min, P < 0.001). The K-flap group showed significantly higher pain on their first postoperative day and significantly less pain after 1 wk (P < 0.001). Conclusions: Although both techniques are safe, the K-flap is associated with significantly lower rates of complications and recurrence and significantly shorter time of wound healing and return to work. ª 2015 Elsevier Inc. All rights reserved.
1.
Introduction
Sacrococcygeal pilonidal disease (SPD) is a chronic inflammation and infection involving the skin and subcutaneous tissues of the sacrococcygeal region. SPD is a common problem that tends to begin after puberty in the teen years with
presentations ranging from asymptomatic pits to painful draining lesions [1]. The incidence has been estimated from 26e700 per 100,000 [2,3]. Historically, it is not an ancient disease. For the first time in 1833, Herbert Mayo described a hair containing sinus. Hodges, who suggested the phrase “pilonidal disease” in 1880, believed it was a congenital
* Corresponding author. Department of Surgery, Imam Khomeini Complex Hospital, Keshavarz Blvd, Tehran, Iran. Tel.: þ98 912 1147406; fax: þ98 21 66581657. E-mail address: [email protected] (M.R. Keramati). 0022-4804/$ e see front matter ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2015.05.039
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 8 ( 2 0 1 5 ) 2 6 0 e2 6 6
condition [1]. Nowadays, most authors have accepted that SPD is an acquired condition, which starts with trapped hair in the natal cleft. Many surgical treatment methods have been described for the treatment of SPD. The surgical treatments are generally divided into two major categories including excision of the diseased tissue with primary closure (including various flap techniques) versus excision with healing by secondary intention (EHSI). EHSI is one of the most popular and widely used surgical procedures as this procedure is simple and safe. In one hand, a number of studies demonstrated an estimated 60% reduction in the risk of recurrent disease after EHSI comparing with midline primary closure [4e13]. On the other hand, a clear advantage has been shown for off-midline closure in comparison with midline closure [14]. In addition, a Cochrane systematic review did not demonstrate obvious advantage of EHSI versus surgical closure but they showed a clear benefit for off-midline closure rather than midline closure [15]. According to the mentioned data, the superiority of EHSI and off-midline closure over midline closure is clear [14] but limited data are available directly comparing EHSI with offmidline closure. The present prospective, controlled, randomized clinical trial study was designed to compare the effects and outcomes of the Karydakis flap (K-flap) procedure as an off-midline primary closure technique with the EHSI technique. Up to this moment, this study is the largest clinical trial that has been conducted to compare these two surgical techniques for treatment of SPD.
2.
Materials and methods
This controlled, prospective, randomized clinical trial study was carried out between September 2007 and March 2014. The study has been registered on the clinicaltrials.gov database under the code NCT00716937. The study has been accepted by the Ethical Committee of Tehran University of Medical Sciences. Informed consent was obtained from all the patients before they were included in the study.
2.1.
Study protocol
This study included patients diagnosed with SPD. Patients were randomly assigned a code group according to the order in which they were included in the study. Therefore, patients were randomly categorized into two groups, using a table created on computer software, for surgical management of their pilonidal disease, including K-flap group and EHSI group. The surgeon was informed of the procedure for each case in the operating room by the moderator of the research, and the surgeon was not allowed to change the assigned procedure in the operating room. Age, gender, body mass index (BMI), operation time, length and width and weight of the excised part, postoperative pain (first day, first week, and first month after operation), time of complete wound healing, time of return to work, postoperative complications, patient satisfaction (first year after operation), and recurrence rate were recorded and compared between the two groups. Variables including number of
261
midline pits, number of lateral secondary openings, distance between cranial and caudal pits, distance between the caudal pit and the anus, and distance between the farthest lateral secondary opening and the midline were also used as measures for comparison between the two groups. The postoperative pain was assessed using a visual analog scale scored from 1e10. Overall patients’ satisfaction was also evaluated in a scale of 0 (lowest) to 5 (highest). Wounds were recorded as healed when they were completely closed without any discharge and not required to be covered by gauze. Recurrence of disease was defined as detection of new orifices after complete healing. Wounds not healed within the first 3 mo after the operation were considered as delayed healing. All the operations were done in the prone position and under general anesthesia. All patients received 1 g of cefazolin intravenously during the operation. Methylene blue was injected through all sinus openings to visualize the border of the cysts and all tracts. The Karydakis procedure was performed in the K-flap group as in the following. Using a probe, limits of the pilonidal cavity were marked. A paramedian line 2 cm from the natal cleft was drawn on the same side of lateral secondary openings or scars. Using the mentioned line, an ellipse was drawn that included the pilonidal cavity. To avoid the final wound curving toward the anus, the caudal end of the ellipse should be drawn around 3-cm lateral to the midline [16]. We infiltrated the edge of the ellipse with adrenaline 1 in 200,000 without lidocaine (instead of adrenaline with lidocaine). The lateral edge of the ellipse was incised at an angle of 45 to the skin, and the medial edge was incised perpendicular to the skin down to the thoracolumbar fascia. The specimen was removed, weighed, and sent for pathologic examination. Hemostasis was secured. A flap was mobilized along the entire medial edge of the ellipse. The deep limit of the medial flap and the longitudinal midline of the base of the ellipse were approximated using interrupted 0 polyglactin (Vicryl; Ethicon, Somerville, NJ) sutures. Another interrupted 2.0 polyglactin (Vicryl; Ethicon) layer of sutures was placed between the free edge of the medial flap and the lateral edge of the wound. The skin was closed with subcuticular 3.0 poliglecaprone (Monocryl; Ethicon) sutures. The wound was also dressed with sterile dressing. In the EHSI group, using an ellipsoid incision, all midline pits and lateral secondary openings were excised to the level of the thoracolumbar fascia. Homeostasis was secured using diathermy, and the wound was packed with wet gauze to obtain healing through granulation. Patients in both groups were discharged 24 h after the surgery. Patients were advised to take care of their wounds from possible direct traumas without any limitation of their activity. Although the hairs of the sacrococcygeal region were shaved before the operation, we did not advise patients for hair removal after the operation. There was no need for postoperative tissue debridement in each group as well. In the EHSI group, the patients were advised to cover their open wound with dressing regularly. Wound coverage was also advised for the K-flap group until full epithelialization of the surgical wound and lack of any discharge from the wound. All patients underwent routine examinations in the first 3 mo postoperatively and were then followed up for recurrence annually at the outpatient clinic by a surgeon.
262 2.2.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 8 ( 2 0 1 5 ) 2 6 0 e2 6 6
Statistical analysis
Statistical analysis was carried out using the Statistical Package for Social Science (SPSS) version 20 (IBM, SPSS, Chicago, IL). Pearson chi-square test was used to compare qualitative variables between the two groups. Comparison of the quantitative variables was performed using the independent samples t-test. P values
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Karydakis flap versus excision-only technique in pilonidal disease Amir Keshvari, MD,a Mohammad Reza Keramati, MD,a,* Mohammad Sadegh Fazeli, MD,a Alireza Kazemeini, MD,a Alipasha Meysamie, MD,b and Mohammad Kazem Nouritaromlou, MDa a
Department of Surgery, Imam Khomeini Complex Hospital, Tehran University of Medical Sciences, Tehran, Iran Department of Community and Preventive Medicine, Medical Faculty, Tehran University of Medical Sciences, Tehran, Iran
b
article info
abstract
Article history:
Background: Karydakis flap (K-flap) and excision with healing by secondary intention (EHSI)
Received 28 February 2015
are currently accepted methods for surgical management of sacrococcygeal pilonidal
Received in revised form
disease. This clinical trial study aimed to compare early and late outcomes of these two
4 May 2015
surgical techniques.
Accepted 21 May 2015
Materials and methods: In this controlled, prospective, randomized clinical trial, patients
Available online 28 May 2015
diagnosed with sacrococcygeal pilonidal disease were randomly allocated to two groups. Patients in the first group underwent Karydakis procedure, whereas EHSI was the surgical
Keywords:
management in the second group. The two techniques were compared based on their
Pilonidal sinus
overall time of wound healing, return to work, rate of complications, and recurrence.
Surgical flap
Results: A total of 321 patients including 161 in the K-flap group and 160 in the EHSI group
Wound healing
were included in the study. The median follow-up duration was 49 mo. The mean time of
Recurrence
wound healing (16.44 versus 80.01 d, P < 0.001), return to work (14.44 versus 24.19, P < 0.001), rate of wound complications (18.7% versus 31.2%, P ¼ 0.006), and recurrence (1.2% versus 7.5%, P ¼ 0.005) were all significantly lower in the K-flap group. The mean operation time was significantly shorter in the EHSI group (15.87 versus 55.17 min, P < 0.001). The K-flap group showed significantly higher pain on their first postoperative day and significantly less pain after 1 wk (P < 0.001). Conclusions: Although both techniques are safe, the K-flap is associated with significantly lower rates of complications and recurrence and significantly shorter time of wound healing and return to work. ª 2015 Elsevier Inc. All rights reserved.
1.
Introduction
Sacrococcygeal pilonidal disease (SPD) is a chronic inflammation and infection involving the skin and subcutaneous tissues of the sacrococcygeal region. SPD is a common problem that tends to begin after puberty in the teen years with
presentations ranging from asymptomatic pits to painful draining lesions [1]. The incidence has been estimated from 26e700 per 100,000 [2,3]. Historically, it is not an ancient disease. For the first time in 1833, Herbert Mayo described a hair containing sinus. Hodges, who suggested the phrase “pilonidal disease” in 1880, believed it was a congenital
* Corresponding author. Department of Surgery, Imam Khomeini Complex Hospital, Keshavarz Blvd, Tehran, Iran. Tel.: þ98 912 1147406; fax: þ98 21 66581657. E-mail address: [email protected] (M.R. Keramati). 0022-4804/$ e see front matter ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2015.05.039
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 8 ( 2 0 1 5 ) 2 6 0 e2 6 6
condition [1]. Nowadays, most authors have accepted that SPD is an acquired condition, which starts with trapped hair in the natal cleft. Many surgical treatment methods have been described for the treatment of SPD. The surgical treatments are generally divided into two major categories including excision of the diseased tissue with primary closure (including various flap techniques) versus excision with healing by secondary intention (EHSI). EHSI is one of the most popular and widely used surgical procedures as this procedure is simple and safe. In one hand, a number of studies demonstrated an estimated 60% reduction in the risk of recurrent disease after EHSI comparing with midline primary closure [4e13]. On the other hand, a clear advantage has been shown for off-midline closure in comparison with midline closure [14]. In addition, a Cochrane systematic review did not demonstrate obvious advantage of EHSI versus surgical closure but they showed a clear benefit for off-midline closure rather than midline closure [15]. According to the mentioned data, the superiority of EHSI and off-midline closure over midline closure is clear [14] but limited data are available directly comparing EHSI with offmidline closure. The present prospective, controlled, randomized clinical trial study was designed to compare the effects and outcomes of the Karydakis flap (K-flap) procedure as an off-midline primary closure technique with the EHSI technique. Up to this moment, this study is the largest clinical trial that has been conducted to compare these two surgical techniques for treatment of SPD.
2.
Materials and methods
This controlled, prospective, randomized clinical trial study was carried out between September 2007 and March 2014. The study has been registered on the clinicaltrials.gov database under the code NCT00716937. The study has been accepted by the Ethical Committee of Tehran University of Medical Sciences. Informed consent was obtained from all the patients before they were included in the study.
2.1.
Study protocol
This study included patients diagnosed with SPD. Patients were randomly assigned a code group according to the order in which they were included in the study. Therefore, patients were randomly categorized into two groups, using a table created on computer software, for surgical management of their pilonidal disease, including K-flap group and EHSI group. The surgeon was informed of the procedure for each case in the operating room by the moderator of the research, and the surgeon was not allowed to change the assigned procedure in the operating room. Age, gender, body mass index (BMI), operation time, length and width and weight of the excised part, postoperative pain (first day, first week, and first month after operation), time of complete wound healing, time of return to work, postoperative complications, patient satisfaction (first year after operation), and recurrence rate were recorded and compared between the two groups. Variables including number of
261
midline pits, number of lateral secondary openings, distance between cranial and caudal pits, distance between the caudal pit and the anus, and distance between the farthest lateral secondary opening and the midline were also used as measures for comparison between the two groups. The postoperative pain was assessed using a visual analog scale scored from 1e10. Overall patients’ satisfaction was also evaluated in a scale of 0 (lowest) to 5 (highest). Wounds were recorded as healed when they were completely closed without any discharge and not required to be covered by gauze. Recurrence of disease was defined as detection of new orifices after complete healing. Wounds not healed within the first 3 mo after the operation were considered as delayed healing. All the operations were done in the prone position and under general anesthesia. All patients received 1 g of cefazolin intravenously during the operation. Methylene blue was injected through all sinus openings to visualize the border of the cysts and all tracts. The Karydakis procedure was performed in the K-flap group as in the following. Using a probe, limits of the pilonidal cavity were marked. A paramedian line 2 cm from the natal cleft was drawn on the same side of lateral secondary openings or scars. Using the mentioned line, an ellipse was drawn that included the pilonidal cavity. To avoid the final wound curving toward the anus, the caudal end of the ellipse should be drawn around 3-cm lateral to the midline [16]. We infiltrated the edge of the ellipse with adrenaline 1 in 200,000 without lidocaine (instead of adrenaline with lidocaine). The lateral edge of the ellipse was incised at an angle of 45 to the skin, and the medial edge was incised perpendicular to the skin down to the thoracolumbar fascia. The specimen was removed, weighed, and sent for pathologic examination. Hemostasis was secured. A flap was mobilized along the entire medial edge of the ellipse. The deep limit of the medial flap and the longitudinal midline of the base of the ellipse were approximated using interrupted 0 polyglactin (Vicryl; Ethicon, Somerville, NJ) sutures. Another interrupted 2.0 polyglactin (Vicryl; Ethicon) layer of sutures was placed between the free edge of the medial flap and the lateral edge of the wound. The skin was closed with subcuticular 3.0 poliglecaprone (Monocryl; Ethicon) sutures. The wound was also dressed with sterile dressing. In the EHSI group, using an ellipsoid incision, all midline pits and lateral secondary openings were excised to the level of the thoracolumbar fascia. Homeostasis was secured using diathermy, and the wound was packed with wet gauze to obtain healing through granulation. Patients in both groups were discharged 24 h after the surgery. Patients were advised to take care of their wounds from possible direct traumas without any limitation of their activity. Although the hairs of the sacrococcygeal region were shaved before the operation, we did not advise patients for hair removal after the operation. There was no need for postoperative tissue debridement in each group as well. In the EHSI group, the patients were advised to cover their open wound with dressing regularly. Wound coverage was also advised for the K-flap group until full epithelialization of the surgical wound and lack of any discharge from the wound. All patients underwent routine examinations in the first 3 mo postoperatively and were then followed up for recurrence annually at the outpatient clinic by a surgeon.
262 2.2.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 8 ( 2 0 1 5 ) 2 6 0 e2 6 6
Statistical analysis
Statistical analysis was carried out using the Statistical Package for Social Science (SPSS) version 20 (IBM, SPSS, Chicago, IL). Pearson chi-square test was used to compare qualitative variables between the two groups. Comparison of the quantitative variables was performed using the independent samples t-test. P values
