- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03426449
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- mansourau45
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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