Fistulotomy Versus Fistulotomy With Marsupialization

Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial

It was a study comparing two standard procedures for fistula in ano

Study Overview

• Status: Completed
• Conditions: Fistula in Ano
• Intervention / Treatment: Procedure: standard fistulotomy; Procedure: fistulotomy with marsupialization

Detailed Description

It was a study which compared two standard surgical procedures for fistula in ano

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Kpk
    • Mardan, Kpk, Pakistan
      • DHQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• having low lying anal fistula Willing to enroll in study

Exclusion Criteria:

• unfit pts Having uncontrolled diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fistulotomy; Standard fistulotomy was done in this arm	Procedure: standard fistulotomy; in a standard manner fistula tract was identified and laid open without doing marsupialization; Procedure: fistulotomy with marsupialization; in this arm fistulotomy was done in a standard manner and marsupialization was done
Other: Fistulotomy with marsupialization; This arm consists of fistulotomy in which marsupialization was done	Procedure: standard fistulotomy; in a standard manner fistula tract was identified and laid open without doing marsupialization; Procedure: fistulotomy with marsupialization; in this arm fistulotomy was done in a standard manner and marsupialization was done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of healing time in fistula in ano with and without marsupialization	We measured the healing time between two groups	1year

Collaborators and Investigators

• Sponsor: DHQ mardan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: 188-40

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