Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

Study Overview
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Brief Summary
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The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

Detailed Description
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The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Official Title
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Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial

Conditions
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Anal Fissure

Intervention / Treatment
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* Procedure: posterolateral sphincterotomy
* Procedure: lateral sphincterotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of both genders with chronic posterior anal fissure were included to the study. Exclusion Criteria: Patients with anterior or lateral anal fissure, patients with previous anal surgery, patients with concomitant anorectal pathology, patients with secondary anal fissure due to Crohn's disease or other specific etiology, patients with any degree of fecal incontinence, patients with active anorectal sepsis.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Posterolateral sphincterotomy<br>Division of internal anal sphincter at 5 o'clock position | Procedure: posterolateral sphincterotomy<br>* Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm<br>|
| Active Comparator: Lateral sphincterotomy<br>Division of internal anal sphincter at 3 o'clock position | Procedure: lateral sphincterotomy<br>* Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of healing | The time to complete healing of anal wound defined by complete epithelization of the wound | 6-8 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal pain | Degree of postoperative pain assessed by pain visual analogue scale ranging from 0-10 where 0 indicates no pain and 10 indicates the worst possible pain | 1-6 weeks after surgery |