Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

February 7, 2018 updated by: Sameh Emile, Mansoura University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Dakahlia
      • Mansourah, Dakahlia, Egypt
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-8 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sameh H Emile, M.D., Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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