Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

Not Applicable

Completed

• Conditions: Anal Fissure
• Interventions: Procedure: posterolateral sphincterotomy; Procedure: lateral sphincterotomy

• Registration Number: NCT03426449
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-07-30
• Study Completion: 2018-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Last Update Submitted: 2018-02-07
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterolateral sphincterotomy	posterolateral sphincterotomy	Division of internal anal sphincter at 5 o'clock position
Lateral sphincterotomy	lateral sphincterotomy	Division of internal anal sphincter at 3 o'clock position

Primary Outcome Measures

Name	Time	Method
Duration of healing	6-8 weeks after surgery	The time to complete healing of anal wound defined by complete epithelization of the wound

Secondary Outcome Measures

Name	Time	Method
Anal pain	1-6 weeks after surgery	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

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt