Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedFebruary 9, 2018
February 1, 2018
2.6 years
February 2, 2018
February 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of healing
The time to complete healing of anal wound defined by complete epithelization of the wound
6-8 weeks after surgery
Secondary Outcomes (1)
Anal pain
1-6 weeks after surgery
Study Arms (2)
Posterolateral sphincterotomy
ACTIVE COMPARATORDivision of internal anal sphincter at 5 o'clock position
Lateral sphincterotomy
ACTIVE COMPARATORDivision of internal anal sphincter at 3 o'clock position
Interventions
Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm
Eligibility Criteria
You may qualify if:
- Adult patients of both genders with chronic posterior anal fissure were included to the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
Related Publications (1)
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.
PMID: 29779044DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D.
Mansoura University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 8, 2018
Study Start
January 1, 2015
Primary Completion
July 30, 2017
Study Completion
January 1, 2018
Last Updated
February 9, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share