NCT05660876

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

December 6, 2022

Last Update Submit

December 14, 2022

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (1)

  • Comparison of healing time in fistula in ano with and without marsupialization

    We measured the healing time between two groups

    1year

Study Arms (2)

Fistulotomy

OTHER

Standard fistulotomy was done in this arm

Procedure: standard fistulotomyProcedure: fistulotomy with marsupialization

Fistulotomy with marsupialization

OTHER

This arm consists of fistulotomy in which marsupialization was done

Procedure: standard fistulotomyProcedure: fistulotomy with marsupialization

Interventions

standard fistulotomyPROCEDURE

in a standard manner fistula tract was identified and laid open without doing marsupialization

FistulotomyFistulotomy with marsupialization
fistulotomy with marsupializationPROCEDURE

in this arm fistulotomy was done in a standard manner and marsupialization was done

FistulotomyFistulotomy with marsupialization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having low lying anal fistula Willing to enroll in study

You may not qualify if:

  • unfit pts Having uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhq

Mardan, Kpk, Pakistan

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant General surgeon

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 21, 2022

Study Start

August 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)