INTRODUCTION
Fistula-in-ano is an abnormal communication between the anal canal and the perianal skin. Anal fistulae originate from the anal glands, which are located between the two anal sphincters that drain into the anal canal. If the outlet of these glands becomes blocked, an abscess can form which may eventually point to the skin surface. The tract formed by this process is the fistula. Fistula-in-ano, though not life-threatening per se, causes considerable morbidity due to pain and drainage of pus and sometimes soiling with stool. It can also serve as a nidus for systemic spread of infection. According to the Parks classification, fistula-in-ano are of inter-sphincteric, trans-sphincteric, supra-sphincteric, and extra-sphincteric types.[1]
Multiple treatments have been described for fistula-in-ano; however, the ideal treatment remains elusive. The treatment of fistula-in-ano is a tight-rope walk between preserving continence and preventing recurrence.[2] Treatments currently practised to treat fistula-in-ano include fistulotomy, cutting seton, seton stitch, fistulectomy, fibrin glue injection, fistula plug, endorectal advancement flap, fistula-tract laser closure, ligation of inter-sphincteric fistula tract, and fistula clip closure.[3456789]
In spite of the availability of various treatments, consensus cannot be reached as to the best form of treatment with regard to recurrence and incontinence. Fistulotomy and fistulectomy remain the two most commonly practiced surgeries for this fairly common problem.[10] There is limited research on the recurrence and incontinence rates of these two procedures, especially in India. Hence, a study was undertaken to compare the recurrence rates and fecal incontinence in patients undergoing fistulotomy or fistulectomy in the Indian setting.
MATERIALS AND METHODS
One hundred and ten patients above the age of 18 years and both sexes having primary or recurrent fistula-in-ano of low anal type (inter-sphincteric and trans-sphincteric) who underwent fistulectomy or fistulotomy between January 2016 and December 2016 and ready to participate were included after explaining potential advantages, and risks. Recurrent fistulas were included irrespective of the type of primary surgery. Permission was obtained from the ethics committee and the scientific advisory committee of the institution. Written informed consent was obtained from all the patients. Exclusion criteria were patients with inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, and patients who had preoperative anal incontinence. Based on a previous study,[11] setting an alpha error at 0.05, and power at 80%, sample size of 110 patients was calculated for this prospective observational study by a formula.[12]
Consecutive patients presenting with fistula-in-ano were recruited for the study based on the inclusion and exclusion criteria. The demographic and clinical data were collected. Randomization was not done because of administrative purpose.
The patient was given low spinal anesthesia or general anesthesia and then placed in the lithotomy position or Jack-knife position as required. Anal inspection was done using Sim's speculum. Methylene blue dye was injected with a cannula in the external opening of the fistula to delineate the tract and to find out the internal opening.
Fistulectomy
An elliptical incision was taken around the perianal opening, and tissues were dissected on either side. The lateral skin margin was retracted away from the fistulous tract by Allis forceps and the medial side retracted with claw retractor or right-angled retractor to prevent accidental opening of the anal canal. Methylene blue dye helped in preventing any accidental injury to the fistulous tract. The tract was dissected in the same way till the internal opening and fistulous tract was removed in toto.
Fistulotomy
A fistula probe was passed until it came out of the internal opening. The entire fistula tract was laid open over the fistula probe using electrosurgery. The infected anal gland was cauterized.
After the procedures, the anal pack soaked in betadine and xylocaine jelly was kept, and dressing pads applied.
Postoperatively, patients were monitored for retention of urine, pain, bleeding or any other complications. Oral analgesic diclofenac sodium 75 mg was given as and when required. The day after the surgery, the anal pack was removed, and the patient was made to sit in a Sitz bath. Patients were discharged on the 1st postoperative if they did not have any complications and were advised for follow-up once a week for the 1st month, then every 15 days for the next 2 months and then, once a month for the next 3 months. The first 8 follow-ups were done in the outpatient department (OPD) of surgery. The next two follow-ups were either done in person or via telephone. The final follow-up at 6 months postoperative was done in OPD to assess any recurrence. The patients were required to fill the Wexner's questionnaire at every monthly follow-up to monitor incontinence. A score of <4 indicated that the patient had very mild symptoms. Scores 4–6, 7–12 and ≥ 13 were considered mild, moderate, and severe, respectively. A score of 0 indicated perfect continence and a score of 20 was complete incontinence. Pelvic floor strengthening exercises and high fiber diet were prescribed in patients having incontinence. Patients who had recurrence were evaluated, and re-surgery was offered to them.
Data on categorical variables are presented as n (% of cases). Data on continuous variables are presented as a mean ± standard deviation. Statistical significance of the difference of categorical variables was tested using the Chi-square test. Statistical significance of continuous variables was tested using unpaired t-test for intergroup comparison, whereas paired t-test was used for intra-group comparison. Values of P < 0.05 were considered to be statistically significant. Data were analyzed using the Statistical Package for Social Sciences (SPSS) for Windows, Version 20.0, (IBM Corporation, Armonk, NY, USA) for MS Windows.
RESULTS
The study included 70 male (63.6%) and 40 female (36.4%) patients. Sixty-one (55.5%), 40/110 (36.4%), and 9 (8.1%) patients were ≤40 years, 40 ≤60 years, and >60 years, respectively. Of 110, 70 (63.6%), 66 (60.0%), 71 (64.6%), and 30 (27.3%) patients presented with perianal swelling, pain, discharge, and other symptoms such as itching/fever, respectively. Eighty-three (75.5%) and 27 (24.5%) patients had primary fistula and recurrent fistula, respectively. Seventy-five (68.2%) and 35 (31.8%) patients had simple and complex fistula, respectively. According to the Parks classification, 69 (62.7%) and 41 (37.3%) patients had inter-sphincteric and trans-sphincteric fistula, respectively. Postoperatively, 53 (48.2%), 16 (14.5%), 8 (7.3%), and 6 (5.5%) patients had incontinence, pain, acute retention of urine and bleeding, respectively, at 1st week follow-up. At 6-month follow-up, 9/110 (8.2%) patients had fecal incontinence. Incidence of recurrence was observed in 1 (0.9%), 6 (5.5%), 9 (8.2%), and 12 (10.9%) patients at 3, 4, 5, and 6 months postoperative follow-up, respectively.
As depicted in Table 1, age groups, gender, fistula, fistula type, and Parks classification were comparable between fistulotomy and fistulectomy groups. As shown in Table 2, mean Wexner's score at the 1st week and 6 months postoperatively was comparable between fistulotomy and fistulectomy groups. Mean Wexner's score at 6 months follow-up (intra-group comparison) was significantly less as compared to 1st week follow-up in both fistulotomy and fistulectomy groups. As depicted in Table 3, there was no statistically significant difference in the severity of Wexner's score at 1st week and 6th month postoperative follow-up between the two groups. In fistulectomy group, at 6th month follow-up, Wexner's score was normal in 49/53 (92.5%) patients, whereas in fistulotomy group, at 6th month follow-up, Wexner's score was normal in 52/57 (91.2%) patients. As shown in Table 4, recurrence rates at 3rd, 4th, 5th, and 6th months postoperative follow-up were comparable between the two groups.
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Table 1: Characteristic of patients at baseline
Table 2: Comparison of mean Wexner score postoperatively
Table 3: Comparison of postoperative Wexner's score of incontinence
Table 4: Comparison of recurrence rates postoperatively
DISCUSSION
Fistula-in-ano is a commonly encountered problem in practice. There are various surgical options available for this common problem. Fistulotomy and fistulectomy remain one of the oldest surgical modality. The present study assesses the outcome of these two procedures.
The two important parameters which define the outcome of the procedures for fistula-in-ano are recurrence and fecal incontinence. In the present study, the mean Wexner's score and recurrence rates at 6 months postoperatively follow-up were comparable between fistulotomy and fistulectomy groups. Prospective studies carried out by Chalya and Mabula[13] and Nazeer et al.[14] revealed no recurrence and incontinence in both in fistulectomy and fistulotomy group at the end of 12 months. Studies by Schouten and van Vroonhoven,[15] Visscher et al.,[16] Tozer et al.,[17] Westerterp et al.,[18] Pescatori et al.,[19] and Göttgens et al.[20] as shown in Table 5 have reported a high rate of postoperative fecal incontinence. In the present study, fecal incontinence was observed in 4/53 (7.6%) and 5/57 (8.8%) in fistulectomy and fistulotomy, respectively, at 6 months postoperatively. The rate of fecal incontinence in our study is in accordance with studies conducted by Ratto et al.,[2122] Stremitzer et al.,[23] and Lux and Athanasiadis.[24]
Table 5: Comparison of faecal incontinence after fistulectomy/fistulotomy in various studies
Literature has a varied spectrum of recurrence rate as shown in Table 6. Whereas a very high recurrence rate is reported by van der Hagen et al.,[25] an acceptable recurrence rate has been reported by Abbas et al.,[26] Shafik et al.,[27] Jivapaisarnpong,[28] van Koperen et al.,[29] and Perez et al.,[30] Only Köckerling et al.[31] have reported no recurrence in their study. In the present study, the recurrence rates were 5/53 (9.4%) and 7/57 (12.3%) in fistulectomy and fistulotomy, respectively, at 6 months postoperatively. However, the limitation of our study is that of a short follow-up period of only 6 months, and nonrandomization of the study. Besides, we did not objectively quantify incontinence by manometry studies as this facility was not available at our institution. Furthermore, higher grade fistulas were beyond the scope of this study as these are usually managed by procedures other than the ones being studied.
Table 6: Comparison of recurrence rates after fistulectomy/fistulotomy in various studies
CONCLUSION
Fistulotomy and fistulectomy for primary or recurrent low anal fistulas were equally effective treatment with acceptable rates of recurrence and fecal incontinence at 6 months follow-up after the surgery.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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