Back to resultsPosterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
Primary Purpose
Anal Fissure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
posterolateral sphincterotomy
lateral sphincterotomy
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fissure
Eligibility Criteria
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.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Posterolateral sphincterotomy
Lateral sphincterotomy
Arm Description
Division of internal anal sphincter at 5 o'clock position
Division of internal anal sphincter at 3 o'clock position
Outcomes
Primary Outcome Measures
Duration of healing
The time to complete healing of anal wound defined by complete epithelization of the wound
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03426449
Brief Title
Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
Official Title
Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterolateral sphincterotomy
Arm Type
Active Comparator
Arm Description
Division of internal anal sphincter at 5 o'clock position
Arm Title
Lateral sphincterotomy
Arm Type
Active Comparator
Arm Description
Division of internal anal sphincter at 3 o'clock position
Intervention Type
Procedure
Intervention Name(s)
posterolateral sphincterotomy
Intervention Description
Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
Intervention Type
Procedure
Intervention Name(s)
lateral sphincterotomy
Intervention Description
Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm
Primary Outcome Measure Information:
Title
Duration of healing
Description
The time to complete healing of anal wound defined by complete epithelization of the wound
Time Frame
6-8 weeks after surgery
Secondary Outcome Measure Information:
Title
Anal pain
Description
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
Time Frame
1-6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29779044
Citation
Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.
Results Reference
derived
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Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
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