Surg Today DOI 10.1007/s00595-013-0785-0
ORIGINAL ARTICLE
Long term outcomes after lateral anal sphincterotomy for anal fissure: a retrospective cohort study Ioseff Davies • Llinos Dafydd • Leigh Davies John Beynon
•
Received: 12 March 2013 / Accepted: 8 May 2013 Ó Springer Japan 2013
Abstract Purpose Lateral anal sphincterotomy is the gold standard of surgical treatment for anal fissure. Patients undergoing this procedure are warned about the risk of incontinence; however, there are few reports on long-term outcomes. We conducted this study to investigate long-term outcomes after lateral anal sphincterotomy, focusing specifically on postoperative incontinence. Methods Patients who underwent lateral anal sphincterotomy at a university teaching hospital between 1998 and 2004 were sent questionnaires to allow us to assess their continence according to the Cleveland Continence Score. Results The response rate was 58 % and the responders comprised 25 men and 13 women, with a median age of 49 years (range 16–82 years). The success rate for fissure healing following surgery was 92 %, being significantly more likely in patients with textbook symptoms (p = 0.016) and those with chronic disease (p = 0.006). The overall complication rate was 13.2 %. Long-term objective and symptomatic incontinence were reported by two (5.6 %) patients, one of whom required a colostomy. Conclusion Success rates after lateral anal sphincterotomy were satisfactory, but careful patient selection based
I. Davies (&) L. Dafydd L. Davies J. Beynon Department of Colorectal Surgery, Singleton Hospital, Swansea, Wales e-mail: [email protected] J. Beynon e-mail: [email protected]
on symptoms and disease chronicity may improve results further. Patients with predisposing risk factors for the development of incontinence, particularly multiparous women, are arguably better treated with non-surgical options. Keywords Fissure in ano Fecal incontinence Surgical procedures Operative
Introduction Anal fissures are a common and painful condition, accounting for approximately 10 % of colorectal unit referrals in the United Kingdom [1]. Contemporary management of anal fissures involves an initial conservative approach based on dietary changes to prevent constipation, progressing to medical treatment when required. Herbal remedies for this condition were described as early as the middle ages and diverse pharmaceutical treatments, including laxatives, analgesia, and topical agents such as glyceryl trinitrate and diltiazem are available. However, surgery remains the gold standard of treatment [2]. Historically, this involved anal dilatation and many different sphinterotomy techniques [3], but now internal sphincterotomy, introduced in the 1950s, has become the procedure of choice [1, 4–8]. Incontinence is recognised as a potential complication of any anal surgery, including sphincterotomy, although it has been considered insignificant for many patients. Despite increasing awareness of how much incontinence impairs quality of life [5, 9], data on long-term complication rates following sphincterotomy are lacking. We conducted this study to investigate the long-term outcomes of lateral anal sphincterotomy for the treatment of anal fissure at a
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university teaching hospital to improve the consent process for future patients.
Table 1 Clinical characteristics of the patients Variable Gender M:F, n (%)
Materials and methods Formal ethical approval for the study was granted by the Bridgend, Neath Port Talbot and Swansea local ethics committee. Patients were identified retrospectively from the operating theatre electronic database. The patients’ general practitioners were contacted, as stipulated by the ethics committee, to obtain permission prior to contacting the individual patients, to avoid undue distress to relatives of deceased patients and ascertain patient suitability for the study. Patients deemed suitable for inclusion were subsequently sent a postal questionnaire (see ‘‘Appendix’’), with a second questionnaire sent to non-responders. Patients who had difficulty in completing the questionnaire were offered a telephone consultation by one of the authors of this study. Questions regarding pre- and postoperative continence were structured so as to calculate the Cleveland Continence Score (CCS) [10, 11], thereby introducing an objective assessment measure. The typical symptoms of anal fissure were defined according to the description by Goligher [12] in 1975 and included pain during defecation and persisting for 1–2 h afterwards. All the procedures were performed under general anesthesia at one centre by one of three colorectal surgeons. With the patient placed in the lithotomy position, a lateral anal sphincterotomy was carried out to the level of the dentate line. Statistical analysis appropriate for non-parametric data was conducted using the statistical package for social sciences (SPSS) version 16 (SPSS, Chicago, IL, USA). The Mann–Whitney U test was used for analysis of variance between two groups and the Wilcoxon test for related samples. Logistic regression was used for multivariate analysis and was modelled for two outcome measures: surgical success and overall patient opinion. The data regarding overall patient opinion was simplified by grouping together (‘pleased’ and ‘content’) and (‘unhappy’ and ‘very unhappy’), thereby converting to a binary variable. Continence was re-coded into a continuous variable, giving the change in continence by subtracting the preoperative score from the postoperative score for inclusion in the multivariate analysis.
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25 (65.8 %):13 (34.2 %)
Median age in years
49, range 16–82
Typical pain, n (%)
34 (89.5)
Median acute pain duration in hours
0.5, range 0–24
Median symptom duration in months
6, range \1–48
Pre-operative medical treatment, n (%)
21 (55.3)
Previous anal surgery, n (%)
11 (28.9)
Results Patients Between September, 1998 and October, 2004, 73 patients underwent a lateral anal sphincterotomy procedure, performed by one of three colorectal consultants. After the exclusion of five patients who died of unrelated conditions and two who did not undergo this procedure for an anal fissure, 66 patients were sent questionnaires, 38 of whom responded (22 by post and 13 by telephone), giving a response rate of 58 %. Thus, 28 patients were excluded for the following reasons: their general practitioner failed to reply (n = 11), the patient chose not to participate (n = 6), or the patient failed to reply (n = 11). The median age of the patients who failed to return questionnaires, including those who had died (n = 33) was 43 years (range 15–94 years) vs. 49 years (range 16–82) for those who completed the questionnaires (p = 0.211). The gender distribution of the patients who failed to return the questionnaire was 13 male (39.4 %) and 20 female (60.6 %) compared with 25 male (65.8 %) and 13 female (34.2 %) for the patients who completed the questionnaires (p = 0.027). Symptoms and treatment details Thirty-four (90 %) patients presented with textbook symptoms of anal fissure preoperatively. The median acute duration of the pain was 45 min (range 0–24 h). The median duration of symptoms prior to surgery was 9 months (range 0–48 months) with 21 (55 %) describing initial medical treatment and 11 (29 %) having undergone previous anal surgery. Table 1 summarises the patient details.
Surg Today Table 3 Logistic regression analysis of procedure success
Table 2 Outcomes Variable
Hazard ratio (95 % confidence interval)
p value
Resolution of fissure (%) Variables excluded from final model
Yes
35 (92.1)
No
3 (7.9)
Age
–
0.958
3, range \1–60
Gender
–
0.359
Acute duration of pain
–
0.868
Complications (%)
5 (13.2)
–
0.746
Incontinence (%)
2 (5.3)
Preoperative continence score
Median preoperative continence score Median postoperative continence score
3, range 0–19 3, range 0–12
Preoperative medical treatment
–
0.814
Median difference between post- and preoperative continence scores
0, range -9 to 12
Previous anal surgery
–
0.183
Subsequent operative treatment for fissure (%)
2 (5.3)
Median days until cessation of pain
Overall opinion (%) Pleased
23 (60.5)
Content
7 (18.4)
Unhappy
4 (10.5)
Very unhappy
2 (5.3)
No comment
2 (5.3)
Treatment outcomes Lateral anal sphincterotomy resulted in fissure resolution in 35 (92 %) patients, with a median lag time between the procedure and cessation of pain of 3 days (range \1–60 days). At the time of completing the study questionnaire, two of the three patients with unhealed fissures had undergone repeat lateral anal sphincterotomy (one, at a different hospital), with satisfactory resolution of symptoms, and one was receiving medical treatment with little success and was awaiting further surgical consultation. Three (7.9 %) patients required further treatment for persistent anal symptoms: One had persistent rectal bleeding, but colonoscopy did not identify a specific cause; one underwent further examination of the rectum, under anaesthesia, for bleeding with the identification and excision of a polyp; and one required long-term laxative treatment. Overall satisfaction with the procedure was as follows: pleased, 60.5 % (n = 23); content, 18.4 % (n = 7); unhappy, 10.5 % (n = 4); very unhappy, 5.3 % (n = 2); and 5.3 % (n = 2) did not comment (Table 2).
Variables included in the final model Typical pain
97.253 (2.389–3959)
0.016
Chronic duration of pain
1.138 (1.037–1.248)
0.006
The following variables were included in the logistic regression analysis of procedure success defined as cessation of pain: age, gender, typical pain, acute duration of pain, chronic duration of pain, pre-operative continence score, pre-operative medical treatment, and previous anal surgery (Table 3). The variables independently and significantly associated with successful outcome following lateral anal sphincterotomy in terms of cessation of pain were chronic duration of pain (HR 1.138, 95 % CI 1.04–1.25, p = 0.006) and typical pain (HR 97.253, 95 % CI 2.4–3959, p = 0.016). Further logistic regression analysis was conducted to investigate patient opinion, entering the following variables into the model: time until cessation of pain postoperatively, complications, change in continence score, need for further treatment, age, typical pain, and chronic duration of pain. No variables emerged as independent significant indicators for overall patient satisfaction. Complications The overall complication rate was 13.2 % (Table 2). Complications included abscess requiring incision and drainage with subsequent symptomatic incontinence, confirmed objectively according to the CCS, in one male
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patient; superficial infection that responded to systemic antibiotic treatment in one patient; and incontinence in three patients, the symptoms of which were described by two as mild, which did not objectively worsen their CCS, and by one female patient as severe and eventually requiring a defunctioning colostomy. We decided to consider the patient who required a colostomy as having suffered significant incontinence despite no objective deterioration in her CCS, because her recent CCS was recorded post-colostomy. There was no significant difference between the median pre- and postoperative continence scores (p = 0.073; Table 2). The results relating to change in CCS from preto postoperatively were as follows: no change, 52.6 % (n = 20); deterioration, 10.5 % (n = 4); improvement, 31.6 % (n = 12); and 5.3 % (n = 2) did not comment.
Discussion and conclusions Concerns about the potential complications of surgery, especially incontinence, have led to widespread assessment of alternative medical treatments. However, many studies comparing surgery with alternative treatment options are small and have short follow-up durations. Most agree that short-term fissure healing and fissure recurrence rates following surgical sphincterotomy are in the region of 93–99 % [7, 13] and 10 %, respectively [14]. Our study identified the long-term fissure healing rate following lateral anal sphincterotomy to be 92 %. Glyceryl trinitrate cream is widely used, but healing rates range 40–60 % [7, 15], with recurrence rates as high as 57.5 % [14]. Moreover, patient satisfaction at 6 years was reported by Brown et al. [16] in 2007 to be inferior to that following surgery (56 % satisfaction versus 100 %, p = 0.04). Calcium channel blockers such as Nifedipine may negate the requirement for surgical treatment and its complications, for up to 70 % of patients; however, fissure recurrence rates are again far higher, in the region of 26–65 % [3, 14]. Botulinum toxin muscle injection
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provides temporary relief of muscle spasm, thereby allowing the fissure to heal, with success rates of over 80 % [13, 15] and significantly lower incontinence rates than surgery [17], albeit again at the expense of a significantly higher recurrence rate [14, 17]. Traditionally, the surgical method was not thought to influence treatment outcome [18, 19]; however, the recent Cochrane Collaboration systematic review that assessed 24 trials (3475 patients) concluded that lateral anal sphincterotomy is superior to anal stretch and posterior midline internal anal sphincterotomy in terms of both healing rates and side-effect profile, namely flatus incontinence [6]. Outcomes are thought to be similar for both the open and closed lateral sphincterotomy techniques [6, 20]; however, higher early complication rates have been reported following the open technique, including more severe postoperative pain, bleeding, and wound sepsis [21]. The sphincterotomy length is directly related to incontinence [22]. Furthermore, patients undergoing limited sphincterotomy to just below the fissure apex have reported less postoperative incontinence than those undergoing traditional sphincterotomy extending to the dentate line (10.86 vs. 2.17 %, p = 0.039) in a randomised trial [23]. However, adequate length of the sphincterotomy is vital, as too short a sphincterotomy is associated with higher fissure recurrence rates [4]. Modern techniques are being evaluated to resolve these issues, including intra-operative anal calibre measurements, which allow the sphincterotomy to be slowly extended until a calibre of 30 mm is achieved. This technique is thought to significantly reduce the early incontinence rate and the time for pain to resolve [24]. The literature is divided about dermal flap coverage. A Frankfurt-based surgical team [25] reported far lower incontinence rates at long-term follow up than after standard lateral anal sphincterotomy (5.8 vs. 47.6 %, respectively; p \ 0.05). However, their case load was small with only 30 patients per treatment arm and their incontinence rates following standard lateral anal sphincterotomy were high. Furthermore, flap necrosis is a serious potential complication [1]. In 2010, Pujahari advocated bilateral anal
Surg Today
sphincterotomies with simultaneous incisions at the 3 and 9 o’clock positions, reporting less postoperative pain and recurrences than after the standard unilateral technique [26]. Bleeding, infection, and incontinence are the major potential complications following lateral anal sphincterotomy [21]. Traditionally incontinence was attributed to poor surgical technique [23], or dated non-sphincter sparing procedures [9]. However, evidence suggests that the disease process of the fissure may disrupt the sphincter muscle [27], with incontinence developing in patients with chronic fissures, as a direct result of the fissure [23]. Incontinence rates following lateral anal sphincterotomy and its subsequent effect on quality of life are highly debated. Many published studies report very low rates of, or no incontinence following surgery and suggest any disturbance in continence to be minor [2, 5, 15, 28]. Other studies disagree, reporting high incontinence rates of 30–45 % [29, 30] in the immediate postoperative period. The overall complication rate in our cohort was 13.2 % and the main side effect was incontinence. Only one patient claimed symptomatic incontinence impairing their quality of life and a consistent objective deterioration in their CCS at the time of completing the study questionnaire. However, another patient required a defunctioning colostomy for incontinence, with satisfactory resolution of symptoms, as reflected in her current CCS. According to the CCS, approximately 50 % of our patients had no postoperative change in continence, while nearly 30 % felt their continence improved postoperatively. The reason for this improvement is obvious for the patient who eventually had a colostomy, while for the others, it may be explained by irregular bowel voiding preoperatively for fear of pain being erroneously considered as incontinence by the patient. On the other hand, satisfied patients who were pleased with their operative results may attempt to demonstrate this with perceived improvement in continence. It may also be related to fissure healing and cessation of the chronic sphincter disruption, as previously demonstrated and hypothesised by Hyman in 2004 [2]. The main weakness of this study was the low questionnaire response rate, a common shortcoming of this type of study, compounded by the constraints imposed by the
ethics committee with regard to contacting the patients’ general practitioners for permission prior to enrolling their patients. Comparison of the demographics between the patients who failed to respond to the questionnaire and those who did suggested homogeneity in age, but heterogeneity in gender, with a higher proportion of males returning the questionnaires, clearly introducing bias. Second, as this was a retrospective cohort study, there was no power calculation with subsequent risk of type I and type II errors. The results were dependent on patient memory recall of several subjective measurements, which is clearly open to bias; for example, a patient’s interpretation of a complication may be different to that of a clinician. Third, the changes in CCS did not always correlate with the symptoms, highlighting the subjective influence on such scores despite their attempt to introduce objectivity. Fourth, retrospective analysis of the CCS at two fixed time points did not take into account treatment initiated between the measurements, as clearly demonstrated by the patient who received a defunctioning stoma for incontinence during the time between the lateral anal sphincterotomy and completing the CCS. In contrast, the long follow-up period of at least 5 years confers an advantage over many previous studies that report outcome results based upon very short follow-up periods. Ultimately, the outcomes of this study are representative of real-life expected outcomes following lateral anal shincterotomy. In conclusion, careful patient selection on the basis of history and duration of presenting symptoms may confer better results. Patients with risk factors for the development of postoperative incontinence may be treated more effectively with non-surgical options. Patients of both genders should be warned that incontinence affecting quality of life may occur in approximately 5 % of the cases. Acknowledgments We thank Mr. R Morgan FRCS and Mr. N Carr MD FRCS for permission to study their patients. Conflict of interest Full ethical approval was obtained for the study, no financial support was received and the authors declare no conflicts of interest.
Appendix
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Questionnaire Questions 1-8 are about BEFORE THE OPERATION
1.
Did you suffer from anal pain before your operation?
Y
/
N
2.
Did this pain occur when you opened your bowels?
Y
/
N
3.
Did this pain occur after you opened your bowels?
Y
/
N
4.
How long would this pain last after a bowel motion?: ____hours____minutes
5.
How long before the operation had this pain been affecting you? (please fill in a duration in the space provided, this may be in years, months or weeks) _________________________
6.
Did you have any other anal surgery before this operation? (for example to treat haemorrhoids) Y / N If yes please provide details ________________________________________ ______________________________________________________________________________________________
7.
Were you given medical treatment before the operation? (for example laxatives, analgesia, or cream) Y
/
N
If yes, please answer the following: For how long did you have this treatment?_____________________________ What was the treatment?___________________________________________ _______________________________________________________________ Did it help at all?_________________________________________________ ______________________________________________________________________________________________
Below is a box that will allow us to score your level of continence BEFORE THE OPERATION. There are 5 types of incontinence. Please circle 1 number for each type of incontinence. The numbers are defined below the table. Types of Incontinence Solid Liquid Gas Need to wear a pad Lifestyle affected
Never 0 0 0 0 0
Rarely 1 1 1 1 1
Sometimes 2 2 2 2 2
Usually 3 3 3 3 3
Never = never Rarely = less than once per month Sometimes = less than once per week, but more than once per month Usually = less than once per day but more than once per week Always = more than once per day
Questions 9-13 are about AFTER THE OPERATION
9.
Did the operation stop the pain? If yes:
/
N
how long after the operation did the pain stop?___________________ has it started again since?
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Y
Y
/
N
Always 4 4 4 4 4
Surg Today If no, was the pain? (please circle): WORSE
THE SAME
IMPROVED
10. Did you have any complication(s) after the operation? Y
/
N
If yes, please give details __________________________________________ ______________________________________________________________________________________________ ______________________________________________________________________________________________
11. Did you require further treatment for this condition?
Y
/
N
If yes, please give details __________________________________________ ______________________________________________________________________________________________ ______________________________________________________________________________________________ 12. Below is a box that will allow us to score your level of continence AFTER THE OPERATION. There are 5 types of incontinence. Please circle 1 number for each type of incontinence. The numbers are defined below the table. Types of Incontinence Solid Liquid Gas Need to wear a pad Lifestyle affected
Never 0 0 0 0 0
Rarely 1 1 1 1 1
Sometimes 2 2 2 2 2
Usually 3 3 3 3 3
Always 4 4 4 4 4
Never = 0 (never), Rarely = less than once per month Sometimes = less than once per week, but more than once per month Usually = less than once per day but more than once per week Always = more than once per day
13. Please circle one of the following to describe your OVERALL opinion of the operation:
PLEASED
CONTENT
UNHAPPY
VERY UNHAPPY
Questions 14-17 are for WOMEN ONLY
14. Have you had children?
Y
/
N
/
N
/
N
If no, please ignore the following questions. If yes please continue.
15. Were any of your children born through vaginal delivery?
Y
If no, please ignore the following questions. If yes please continue.
16. Did you have any assistance with your delivery? (e.g. forceps) Y
Please give details ________________________________________________
17. Were any of your children born after this operation?
Y
/
N
If yes, please give details about any changes in continence experienced after childbirth _______________________________________________________ ______________________________________________________________________________________________
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References 1. Poh A, Tan K, Seow-Choen F. Innovations in chronic anal fissure treatment: a systematic review. World J Gastrointest Surg. 2010;2(7):231–41. 2. Hyman N. Incontinence after lateral internal sphincterotomy: a prospective study and quality of life assessment. Dis Colon Rectum. 2004;47:35–8. 3. Golfam F, Golfam P, Khalaj A, Sayed Mortaz SS. The effect of topical Nifedipine in treatment of chronic anal fissure. Acta Med Iran. 2010;48(5):295–9. 4. Karandikar S, Brown GM, Carr ND, Beynon J. Attitudes to the treatment of chronic anal fissure in ano after failed medical treatment. Colorectal Dis. 2002;5:569–72. 5. Siddique MI, Murshed KM, Majid MA. Comparative study of lateral internal sphincterotomy versus local 0.2 % glyceryl trinitrate ointment for the treatment of chronic anal fissure. Bangladesh Med Res Counc Bull. 2008;34(1):12–5. 6. Nelson RL. Operative procedures for fissure in ano. Cochrane Database Syst Rev 2010; (1):CD002199. doi:10.1002/14651858. CD002199.pub3. 7. Karamanlis E, Michalopoulos A, Papadopoulos V, Mekras A, Panagiotou D, Ioannidis A, Basdanis G, Fahantidis E. Prospective clinical trial comparing sphincterotomy, nitroglycerin ointment and xylocaine/lactulose combination for the treatment of anal fissure. Tech Coloproctol. 2010;14(1):S21–3. 8. Tocchi A, Mazzoni G, Miccini M, Cassini D, Bettelli E, Brozzetti S. Total lateral sphincterotomy for anal fissure. Int J Colorectal Dis. 2004;19:245–9. 9. Lindsey I, Jones OM, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ. Patterns of fecal incontinence after anal surgery. Dis Colon Rectum. 2004;47:1643–9. 10. Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence. Dis Colon Rectum. 1999;42:1525–32. 11. Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal incontinence quality of life scale quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000;43: 9–17. 12. Goligher JC. Surgery of the anus, rectum and colon. 3rd ed. London: Balliere & Tindall; 1975. 13. Sileri P, Stolfi VM, Franceschilli L, Grande M, Di Giorgio A, D’Ugo S, Attina’ G, D’Eletto M, Gaspari AL. Conservative and surgical treatment of chronic anal fissure: prospective longer term results. J Gastrointest Surg. 2010;14(5):773–80. 14. Abd Elhady HM, Othman IH, Hablus MA, Ismail TA, Aboryia MH, Selim MF. Long-term prospective randomised clinical and manometric comparison between surgical and chemical sphincterotomy for treatment of chronic anal fissure. S Afr J Surg. 2009;47(4):112–4. 15. Sileri P, Mele A, Stolfi VM, Grande M, Sica G, Gentileschi P, Di Carlo S, Gaspari AL. Medical and surgical treatment of chronic anal fissure: a prospective study. J Gastrointest Surg. 2007;11(11): 1541–8. 16. Brown CJ, Dubreuil D, Santoro L, Liu M, O’Connor BI, McLeod RS. Lateral internal sphincterotomy is superior to topical nitroglycerin
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17.
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29.
30.
for healing chronic anal fissure and does not compromise long-term fecal continence: six-year follow-up of a multicenter, randomized, controlled trial. Dis Colon Rectum. 2007;50(4):442–8. Nasr M, Ezzat H, Elsebae M. Botulinum toxin injection versus lateral internal sphinctertomy in the treatment of chronic anal fissure: a randomized controlled trial. World J Surg. 2010;34(11): 2730–4. Arroyo A, Pe´rez F, Serrano P, Candela F, Calpena R. Open versus closed lateral sphincterotomy performed as an outpatient procedure under local anaesthesia for chronic anal fissure: prospective randomised study of clinical and manometric longterm results. J Am Coll Surg. 2004;199:361–7. Yucel T, Gonullu D, Oncu M, Koksoy FN, Ozkan SG, Aycan O. Comparison of controlled-intermittent anal dilatation and lateral internal sphincterotomy in the treatment of chronic anal fissures: a prospective, randomized study. Int J Surg. 2009;7(3):228–31. Wiley M, Day P, Rieger N, Stephens J, Moore J. Open vs. closed lateral internal sphincterotomy for idiopathic fissure-in-ano: a prospective, randomised, controlled trial. Dis Colon Rectum. 2004;47:847–52. Kang GS, Kim BS, Choi PS, Kang DW. Evaluation of healing and complications after lateral internal sphincterotomy for chronic anal fissure: marginal suture of incision vs. open left incision: prospective, randomized, controlled study. Dis Colon Rectum. 2008;51(3):329–33. Garcia-Aguilar J, Belmonte Montes C, Perez JJ, Jensen L, Madoff RD, Wong WD. Incontinence after lateral internal sphincterotomy anatomic and functional evaluation. Dis Colon Rectum. 1998;41:423–7. Elsebae MM. A study of fecal incontinence in patients with chronic anal fissure: prospective, randomized, controlled trial of the extent of internal anal sphincter division during lateral sphincterotomy. World J Surg. 2007;31(10):2052–7. Mentes¸ BB, Gu¨ner MK, Leventoglu S, Akyu¨rek N. Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex. Dis Colon Rectum. 2008;51(1):128–33. Hancke E, Rikas E, Suchan K, Vo¨lke K. Dermal flap coverage for chronic anal fissure: lower incidence of anal incontinence compared to lateral internal sphincterotomy after long-term followup. Dis Colon Rectum. 2010;53(11):1563–8. Pujahari AK. Unilateral versus bilateral lateral internal sphincterotomy: a randomized controlled trial for chronic fissure in ano. Trop Gastroenterol. 2010;31(1):69–71. Ammari FF, Bani-Hani KE. Faecal incontinence in patients with anal fissure: a consequence of internal sphincterotomy or a feature of the condition? Surg J R Coll Surg Edinb Irel. 2004;2(4):225–9. Arslan K, Erenoglu B, Dogru O, Turan E, Eryilmaz MA, Atay A, Kokcam S. Lateral internal sphincterotomy versus 0.25 % isosorbide dinitrate ointment for chronic anal fissures: a prospective randomized controlled trial. Surg Today. 2013;43(5):500–5. Casillas S, Hull TL, Zutshi M, Trzcinski R, Bast JF, Xu M. Incontinence after a lateral internal sphincterotomy: are we understanding it? Dis Colon Rectum. 2005;48:1193–9. Nyam DCNK, Pemberton JH. Long-term results of lateral internal sphincterotomy for chronic anal fissure with particular reference to incidence of fecal incontinence. Dis Colon Rectum. 1999;42(10):1306–10.
ORIGINAL ARTICLE
Long term outcomes after lateral anal sphincterotomy for anal fissure: a retrospective cohort study Ioseff Davies • Llinos Dafydd • Leigh Davies John Beynon
•
Received: 12 March 2013 / Accepted: 8 May 2013 Ó Springer Japan 2013
Abstract Purpose Lateral anal sphincterotomy is the gold standard of surgical treatment for anal fissure. Patients undergoing this procedure are warned about the risk of incontinence; however, there are few reports on long-term outcomes. We conducted this study to investigate long-term outcomes after lateral anal sphincterotomy, focusing specifically on postoperative incontinence. Methods Patients who underwent lateral anal sphincterotomy at a university teaching hospital between 1998 and 2004 were sent questionnaires to allow us to assess their continence according to the Cleveland Continence Score. Results The response rate was 58 % and the responders comprised 25 men and 13 women, with a median age of 49 years (range 16–82 years). The success rate for fissure healing following surgery was 92 %, being significantly more likely in patients with textbook symptoms (p = 0.016) and those with chronic disease (p = 0.006). The overall complication rate was 13.2 %. Long-term objective and symptomatic incontinence were reported by two (5.6 %) patients, one of whom required a colostomy. Conclusion Success rates after lateral anal sphincterotomy were satisfactory, but careful patient selection based
I. Davies (&) L. Dafydd L. Davies J. Beynon Department of Colorectal Surgery, Singleton Hospital, Swansea, Wales e-mail: [email protected] J. Beynon e-mail: [email protected]
on symptoms and disease chronicity may improve results further. Patients with predisposing risk factors for the development of incontinence, particularly multiparous women, are arguably better treated with non-surgical options. Keywords Fissure in ano Fecal incontinence Surgical procedures Operative
Introduction Anal fissures are a common and painful condition, accounting for approximately 10 % of colorectal unit referrals in the United Kingdom [1]. Contemporary management of anal fissures involves an initial conservative approach based on dietary changes to prevent constipation, progressing to medical treatment when required. Herbal remedies for this condition were described as early as the middle ages and diverse pharmaceutical treatments, including laxatives, analgesia, and topical agents such as glyceryl trinitrate and diltiazem are available. However, surgery remains the gold standard of treatment [2]. Historically, this involved anal dilatation and many different sphinterotomy techniques [3], but now internal sphincterotomy, introduced in the 1950s, has become the procedure of choice [1, 4–8]. Incontinence is recognised as a potential complication of any anal surgery, including sphincterotomy, although it has been considered insignificant for many patients. Despite increasing awareness of how much incontinence impairs quality of life [5, 9], data on long-term complication rates following sphincterotomy are lacking. We conducted this study to investigate the long-term outcomes of lateral anal sphincterotomy for the treatment of anal fissure at a
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university teaching hospital to improve the consent process for future patients.
Table 1 Clinical characteristics of the patients Variable Gender M:F, n (%)
Materials and methods Formal ethical approval for the study was granted by the Bridgend, Neath Port Talbot and Swansea local ethics committee. Patients were identified retrospectively from the operating theatre electronic database. The patients’ general practitioners were contacted, as stipulated by the ethics committee, to obtain permission prior to contacting the individual patients, to avoid undue distress to relatives of deceased patients and ascertain patient suitability for the study. Patients deemed suitable for inclusion were subsequently sent a postal questionnaire (see ‘‘Appendix’’), with a second questionnaire sent to non-responders. Patients who had difficulty in completing the questionnaire were offered a telephone consultation by one of the authors of this study. Questions regarding pre- and postoperative continence were structured so as to calculate the Cleveland Continence Score (CCS) [10, 11], thereby introducing an objective assessment measure. The typical symptoms of anal fissure were defined according to the description by Goligher [12] in 1975 and included pain during defecation and persisting for 1–2 h afterwards. All the procedures were performed under general anesthesia at one centre by one of three colorectal surgeons. With the patient placed in the lithotomy position, a lateral anal sphincterotomy was carried out to the level of the dentate line. Statistical analysis appropriate for non-parametric data was conducted using the statistical package for social sciences (SPSS) version 16 (SPSS, Chicago, IL, USA). The Mann–Whitney U test was used for analysis of variance between two groups and the Wilcoxon test for related samples. Logistic regression was used for multivariate analysis and was modelled for two outcome measures: surgical success and overall patient opinion. The data regarding overall patient opinion was simplified by grouping together (‘pleased’ and ‘content’) and (‘unhappy’ and ‘very unhappy’), thereby converting to a binary variable. Continence was re-coded into a continuous variable, giving the change in continence by subtracting the preoperative score from the postoperative score for inclusion in the multivariate analysis.
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25 (65.8 %):13 (34.2 %)
Median age in years
49, range 16–82
Typical pain, n (%)
34 (89.5)
Median acute pain duration in hours
0.5, range 0–24
Median symptom duration in months
6, range \1–48
Pre-operative medical treatment, n (%)
21 (55.3)
Previous anal surgery, n (%)
11 (28.9)
Results Patients Between September, 1998 and October, 2004, 73 patients underwent a lateral anal sphincterotomy procedure, performed by one of three colorectal consultants. After the exclusion of five patients who died of unrelated conditions and two who did not undergo this procedure for an anal fissure, 66 patients were sent questionnaires, 38 of whom responded (22 by post and 13 by telephone), giving a response rate of 58 %. Thus, 28 patients were excluded for the following reasons: their general practitioner failed to reply (n = 11), the patient chose not to participate (n = 6), or the patient failed to reply (n = 11). The median age of the patients who failed to return questionnaires, including those who had died (n = 33) was 43 years (range 15–94 years) vs. 49 years (range 16–82) for those who completed the questionnaires (p = 0.211). The gender distribution of the patients who failed to return the questionnaire was 13 male (39.4 %) and 20 female (60.6 %) compared with 25 male (65.8 %) and 13 female (34.2 %) for the patients who completed the questionnaires (p = 0.027). Symptoms and treatment details Thirty-four (90 %) patients presented with textbook symptoms of anal fissure preoperatively. The median acute duration of the pain was 45 min (range 0–24 h). The median duration of symptoms prior to surgery was 9 months (range 0–48 months) with 21 (55 %) describing initial medical treatment and 11 (29 %) having undergone previous anal surgery. Table 1 summarises the patient details.
Surg Today Table 3 Logistic regression analysis of procedure success
Table 2 Outcomes Variable
Hazard ratio (95 % confidence interval)
p value
Resolution of fissure (%) Variables excluded from final model
Yes
35 (92.1)
No
3 (7.9)
Age
–
0.958
3, range \1–60
Gender
–
0.359
Acute duration of pain
–
0.868
Complications (%)
5 (13.2)
–
0.746
Incontinence (%)
2 (5.3)
Preoperative continence score
Median preoperative continence score Median postoperative continence score
3, range 0–19 3, range 0–12
Preoperative medical treatment
–
0.814
Median difference between post- and preoperative continence scores
0, range -9 to 12
Previous anal surgery
–
0.183
Subsequent operative treatment for fissure (%)
2 (5.3)
Median days until cessation of pain
Overall opinion (%) Pleased
23 (60.5)
Content
7 (18.4)
Unhappy
4 (10.5)
Very unhappy
2 (5.3)
No comment
2 (5.3)
Treatment outcomes Lateral anal sphincterotomy resulted in fissure resolution in 35 (92 %) patients, with a median lag time between the procedure and cessation of pain of 3 days (range \1–60 days). At the time of completing the study questionnaire, two of the three patients with unhealed fissures had undergone repeat lateral anal sphincterotomy (one, at a different hospital), with satisfactory resolution of symptoms, and one was receiving medical treatment with little success and was awaiting further surgical consultation. Three (7.9 %) patients required further treatment for persistent anal symptoms: One had persistent rectal bleeding, but colonoscopy did not identify a specific cause; one underwent further examination of the rectum, under anaesthesia, for bleeding with the identification and excision of a polyp; and one required long-term laxative treatment. Overall satisfaction with the procedure was as follows: pleased, 60.5 % (n = 23); content, 18.4 % (n = 7); unhappy, 10.5 % (n = 4); very unhappy, 5.3 % (n = 2); and 5.3 % (n = 2) did not comment (Table 2).
Variables included in the final model Typical pain
97.253 (2.389–3959)
0.016
Chronic duration of pain
1.138 (1.037–1.248)
0.006
The following variables were included in the logistic regression analysis of procedure success defined as cessation of pain: age, gender, typical pain, acute duration of pain, chronic duration of pain, pre-operative continence score, pre-operative medical treatment, and previous anal surgery (Table 3). The variables independently and significantly associated with successful outcome following lateral anal sphincterotomy in terms of cessation of pain were chronic duration of pain (HR 1.138, 95 % CI 1.04–1.25, p = 0.006) and typical pain (HR 97.253, 95 % CI 2.4–3959, p = 0.016). Further logistic regression analysis was conducted to investigate patient opinion, entering the following variables into the model: time until cessation of pain postoperatively, complications, change in continence score, need for further treatment, age, typical pain, and chronic duration of pain. No variables emerged as independent significant indicators for overall patient satisfaction. Complications The overall complication rate was 13.2 % (Table 2). Complications included abscess requiring incision and drainage with subsequent symptomatic incontinence, confirmed objectively according to the CCS, in one male
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patient; superficial infection that responded to systemic antibiotic treatment in one patient; and incontinence in three patients, the symptoms of which were described by two as mild, which did not objectively worsen their CCS, and by one female patient as severe and eventually requiring a defunctioning colostomy. We decided to consider the patient who required a colostomy as having suffered significant incontinence despite no objective deterioration in her CCS, because her recent CCS was recorded post-colostomy. There was no significant difference between the median pre- and postoperative continence scores (p = 0.073; Table 2). The results relating to change in CCS from preto postoperatively were as follows: no change, 52.6 % (n = 20); deterioration, 10.5 % (n = 4); improvement, 31.6 % (n = 12); and 5.3 % (n = 2) did not comment.
Discussion and conclusions Concerns about the potential complications of surgery, especially incontinence, have led to widespread assessment of alternative medical treatments. However, many studies comparing surgery with alternative treatment options are small and have short follow-up durations. Most agree that short-term fissure healing and fissure recurrence rates following surgical sphincterotomy are in the region of 93–99 % [7, 13] and 10 %, respectively [14]. Our study identified the long-term fissure healing rate following lateral anal sphincterotomy to be 92 %. Glyceryl trinitrate cream is widely used, but healing rates range 40–60 % [7, 15], with recurrence rates as high as 57.5 % [14]. Moreover, patient satisfaction at 6 years was reported by Brown et al. [16] in 2007 to be inferior to that following surgery (56 % satisfaction versus 100 %, p = 0.04). Calcium channel blockers such as Nifedipine may negate the requirement for surgical treatment and its complications, for up to 70 % of patients; however, fissure recurrence rates are again far higher, in the region of 26–65 % [3, 14]. Botulinum toxin muscle injection
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provides temporary relief of muscle spasm, thereby allowing the fissure to heal, with success rates of over 80 % [13, 15] and significantly lower incontinence rates than surgery [17], albeit again at the expense of a significantly higher recurrence rate [14, 17]. Traditionally, the surgical method was not thought to influence treatment outcome [18, 19]; however, the recent Cochrane Collaboration systematic review that assessed 24 trials (3475 patients) concluded that lateral anal sphincterotomy is superior to anal stretch and posterior midline internal anal sphincterotomy in terms of both healing rates and side-effect profile, namely flatus incontinence [6]. Outcomes are thought to be similar for both the open and closed lateral sphincterotomy techniques [6, 20]; however, higher early complication rates have been reported following the open technique, including more severe postoperative pain, bleeding, and wound sepsis [21]. The sphincterotomy length is directly related to incontinence [22]. Furthermore, patients undergoing limited sphincterotomy to just below the fissure apex have reported less postoperative incontinence than those undergoing traditional sphincterotomy extending to the dentate line (10.86 vs. 2.17 %, p = 0.039) in a randomised trial [23]. However, adequate length of the sphincterotomy is vital, as too short a sphincterotomy is associated with higher fissure recurrence rates [4]. Modern techniques are being evaluated to resolve these issues, including intra-operative anal calibre measurements, which allow the sphincterotomy to be slowly extended until a calibre of 30 mm is achieved. This technique is thought to significantly reduce the early incontinence rate and the time for pain to resolve [24]. The literature is divided about dermal flap coverage. A Frankfurt-based surgical team [25] reported far lower incontinence rates at long-term follow up than after standard lateral anal sphincterotomy (5.8 vs. 47.6 %, respectively; p \ 0.05). However, their case load was small with only 30 patients per treatment arm and their incontinence rates following standard lateral anal sphincterotomy were high. Furthermore, flap necrosis is a serious potential complication [1]. In 2010, Pujahari advocated bilateral anal
Surg Today
sphincterotomies with simultaneous incisions at the 3 and 9 o’clock positions, reporting less postoperative pain and recurrences than after the standard unilateral technique [26]. Bleeding, infection, and incontinence are the major potential complications following lateral anal sphincterotomy [21]. Traditionally incontinence was attributed to poor surgical technique [23], or dated non-sphincter sparing procedures [9]. However, evidence suggests that the disease process of the fissure may disrupt the sphincter muscle [27], with incontinence developing in patients with chronic fissures, as a direct result of the fissure [23]. Incontinence rates following lateral anal sphincterotomy and its subsequent effect on quality of life are highly debated. Many published studies report very low rates of, or no incontinence following surgery and suggest any disturbance in continence to be minor [2, 5, 15, 28]. Other studies disagree, reporting high incontinence rates of 30–45 % [29, 30] in the immediate postoperative period. The overall complication rate in our cohort was 13.2 % and the main side effect was incontinence. Only one patient claimed symptomatic incontinence impairing their quality of life and a consistent objective deterioration in their CCS at the time of completing the study questionnaire. However, another patient required a defunctioning colostomy for incontinence, with satisfactory resolution of symptoms, as reflected in her current CCS. According to the CCS, approximately 50 % of our patients had no postoperative change in continence, while nearly 30 % felt their continence improved postoperatively. The reason for this improvement is obvious for the patient who eventually had a colostomy, while for the others, it may be explained by irregular bowel voiding preoperatively for fear of pain being erroneously considered as incontinence by the patient. On the other hand, satisfied patients who were pleased with their operative results may attempt to demonstrate this with perceived improvement in continence. It may also be related to fissure healing and cessation of the chronic sphincter disruption, as previously demonstrated and hypothesised by Hyman in 2004 [2]. The main weakness of this study was the low questionnaire response rate, a common shortcoming of this type of study, compounded by the constraints imposed by the
ethics committee with regard to contacting the patients’ general practitioners for permission prior to enrolling their patients. Comparison of the demographics between the patients who failed to respond to the questionnaire and those who did suggested homogeneity in age, but heterogeneity in gender, with a higher proportion of males returning the questionnaires, clearly introducing bias. Second, as this was a retrospective cohort study, there was no power calculation with subsequent risk of type I and type II errors. The results were dependent on patient memory recall of several subjective measurements, which is clearly open to bias; for example, a patient’s interpretation of a complication may be different to that of a clinician. Third, the changes in CCS did not always correlate with the symptoms, highlighting the subjective influence on such scores despite their attempt to introduce objectivity. Fourth, retrospective analysis of the CCS at two fixed time points did not take into account treatment initiated between the measurements, as clearly demonstrated by the patient who received a defunctioning stoma for incontinence during the time between the lateral anal sphincterotomy and completing the CCS. In contrast, the long follow-up period of at least 5 years confers an advantage over many previous studies that report outcome results based upon very short follow-up periods. Ultimately, the outcomes of this study are representative of real-life expected outcomes following lateral anal shincterotomy. In conclusion, careful patient selection on the basis of history and duration of presenting symptoms may confer better results. Patients with risk factors for the development of postoperative incontinence may be treated more effectively with non-surgical options. Patients of both genders should be warned that incontinence affecting quality of life may occur in approximately 5 % of the cases. Acknowledgments We thank Mr. R Morgan FRCS and Mr. N Carr MD FRCS for permission to study their patients. Conflict of interest Full ethical approval was obtained for the study, no financial support was received and the authors declare no conflicts of interest.
Appendix
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Questionnaire Questions 1-8 are about BEFORE THE OPERATION
1.
Did you suffer from anal pain before your operation?
Y
/
N
2.
Did this pain occur when you opened your bowels?
Y
/
N
3.
Did this pain occur after you opened your bowels?
Y
/
N
4.
How long would this pain last after a bowel motion?: ____hours____minutes
5.
How long before the operation had this pain been affecting you? (please fill in a duration in the space provided, this may be in years, months or weeks) _________________________
6.
Did you have any other anal surgery before this operation? (for example to treat haemorrhoids) Y / N If yes please provide details ________________________________________ ______________________________________________________________________________________________
7.
Were you given medical treatment before the operation? (for example laxatives, analgesia, or cream) Y
/
N
If yes, please answer the following: For how long did you have this treatment?_____________________________ What was the treatment?___________________________________________ _______________________________________________________________ Did it help at all?_________________________________________________ ______________________________________________________________________________________________
Below is a box that will allow us to score your level of continence BEFORE THE OPERATION. There are 5 types of incontinence. Please circle 1 number for each type of incontinence. The numbers are defined below the table. Types of Incontinence Solid Liquid Gas Need to wear a pad Lifestyle affected
Never 0 0 0 0 0
Rarely 1 1 1 1 1
Sometimes 2 2 2 2 2
Usually 3 3 3 3 3
Never = never Rarely = less than once per month Sometimes = less than once per week, but more than once per month Usually = less than once per day but more than once per week Always = more than once per day
Questions 9-13 are about AFTER THE OPERATION
9.
Did the operation stop the pain? If yes:
/
N
how long after the operation did the pain stop?___________________ has it started again since?
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Y
Y
/
N
Always 4 4 4 4 4
Surg Today If no, was the pain? (please circle): WORSE
THE SAME
IMPROVED
10. Did you have any complication(s) after the operation? Y
/
N
If yes, please give details __________________________________________ ______________________________________________________________________________________________ ______________________________________________________________________________________________
11. Did you require further treatment for this condition?
Y
/
N
If yes, please give details __________________________________________ ______________________________________________________________________________________________ ______________________________________________________________________________________________ 12. Below is a box that will allow us to score your level of continence AFTER THE OPERATION. There are 5 types of incontinence. Please circle 1 number for each type of incontinence. The numbers are defined below the table. Types of Incontinence Solid Liquid Gas Need to wear a pad Lifestyle affected
Never 0 0 0 0 0
Rarely 1 1 1 1 1
Sometimes 2 2 2 2 2
Usually 3 3 3 3 3
Always 4 4 4 4 4
Never = 0 (never), Rarely = less than once per month Sometimes = less than once per week, but more than once per month Usually = less than once per day but more than once per week Always = more than once per day
13. Please circle one of the following to describe your OVERALL opinion of the operation:
PLEASED
CONTENT
UNHAPPY
VERY UNHAPPY
Questions 14-17 are for WOMEN ONLY
14. Have you had children?
Y
/
N
/
N
/
N
If no, please ignore the following questions. If yes please continue.
15. Were any of your children born through vaginal delivery?
Y
If no, please ignore the following questions. If yes please continue.
16. Did you have any assistance with your delivery? (e.g. forceps) Y
Please give details ________________________________________________
17. Were any of your children born after this operation?
Y
/
N
If yes, please give details about any changes in continence experienced after childbirth _______________________________________________________ ______________________________________________________________________________________________
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