Back to resultsFistulotomy Versus Fistulotomy With Marsupialization
Primary Purpose
Fistula in Ano
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
standard fistulotomy
fistulotomy with marsupialization
Sponsored by
About this trial
This is an interventional treatment trial for Fistula in Ano
Eligibility Criteria
Inclusion Criteria: having low lying anal fistula Willing to enroll in study Exclusion Criteria: unfit pts Having uncontrolled diabetes
Sites / Locations
- Dhq
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Fistulotomy
Fistulotomy with marsupialization
Arm Description
Standard fistulotomy was done in this arm
This arm consists of fistulotomy in which marsupialization was done
Outcomes
Primary Outcome Measures
Comparison of healing time in fistula in ano with and without marsupialization
We measured the healing time between two groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05660876
Brief Title
Fistulotomy Versus Fistulotomy With Marsupialization
Official Title
Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DHQ mardan
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
It was a study comparing two standard procedures for fistula in ano
Detailed Description
It was a study which compared two standard surgical procedures for fistula in ano
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula in Ano
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fistulotomy
Arm Type
Other
Arm Description
Standard fistulotomy was done in this arm
Arm Title
Fistulotomy with marsupialization
Arm Type
Other
Arm Description
This arm consists of fistulotomy in which marsupialization was done
Intervention Type
Procedure
Intervention Name(s)
standard fistulotomy
Intervention Description
in a standard manner fistula tract was identified and laid open without doing marsupialization
Intervention Type
Procedure
Intervention Name(s)
fistulotomy with marsupialization
Intervention Description
in this arm fistulotomy was done in a standard manner and marsupialization was done
Primary Outcome Measure Information:
Title
Comparison of healing time in fistula in ano with and without marsupialization
Description
We measured the healing time between two groups
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
having low lying anal fistula Willing to enroll in study
Exclusion Criteria:
unfit pts Having uncontrolled diabetes
Facility Information:
Facility Name
Dhq
City
Mardan
State/Province
Kpk
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fistulotomy Versus Fistulotomy With Marsupialization
We'll reach out to this number within 24 hrs