Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula

December 2, 2018 updated by: Dr. SamiUllah, Services Hospital, Lahore
It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes and aged 20 years and above with high perianal fistula

Exclusion Criteria:

  • Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: prolene seton
Prolene thread will be used as seton treatment for perianal fistulas
Procedure: prolene seton treatment
patients with perianal fistulas will treated with seton placement by prolene thread
ACTIVE_COMPARATOR: silk seton
Silk thread will be used as seton treatment for perianal fistulas
Procedure: silk seton treatment
patients with perianal fistulas will treated with seton placement by silk thread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fistula healing
Time Frame: 8 to 12 weeks
fistula healing, complete healing of wound with no external opening of fistula
8 to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula recurrence
Time Frame: 6 months
Recurrence of perianal fistula after treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

August 30, 2018

Study Completion (ACTUAL)

August 30, 2018

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

December 2, 2018

First Posted (ACTUAL)

December 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 2, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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