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

Primary Purpose

Perianal Fistula

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
prolene seton treatment
silk seton treatment
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perianal Fistula

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

prolene seton

silk seton

Arm Description

Prolene thread will be used as seton treatment for perianal fistulas

Silk thread will be used as seton treatment for perianal fistulas

Outcomes

Primary Outcome Measures

fistula healing
fistula healing, complete healing of wound with no external opening of fistula

Secondary Outcome Measures

Fistula recurrence
Recurrence of perianal fistula after treatment

Full Information

First Posted
July 10, 2018
Last Updated
December 2, 2018
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT03763981
Brief Title
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
Official Title
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prolene seton
Arm Type
Active Comparator
Arm Description
Prolene thread will be used as seton treatment for perianal fistulas
Arm Title
silk seton
Arm Type
Active Comparator
Arm Description
Silk thread will be used as seton treatment for perianal fistulas
Intervention Type
Procedure
Intervention Name(s)
prolene seton treatment
Intervention Description
patients with perianal fistulas will treated with seton placement by prolene thread
Intervention Type
Procedure
Intervention Name(s)
silk seton treatment
Intervention Description
patients with perianal fistulas will treated with seton placement by silk thread
Primary Outcome Measure Information:
Title
fistula healing
Description
fistula healing, complete healing of wound with no external opening of fistula
Time Frame
8 to 12 weeks
Secondary Outcome Measure Information:
Title
Fistula recurrence
Description
Recurrence of perianal fistula after treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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