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Completed

NCT Number: NCT03426449

Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

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.

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Key information

Conditions

Anal Fissure Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

posterolateral sphincterotomy

Procedure

Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm

lateral sphincterotomy

Procedure

Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

Primary outcomes

  1. Duration of healing

    Time frame: 6-8 weeks after surgery

    The time to complete healing of anal wound defined by complete epithelization of the wound

Secondary outcomes

  1. Anal pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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