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NCT03763981 Clinical Trial

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

Perianal Fistula Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03763981
Other study ID # s5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date August 30, 2018

Study information
Verified date December 2018
Source Services Hospital, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• prolene seton treatment
patients with perianal fistulas will treated with seton placement by prolene thread
• silk seton treatment
patients with perianal fistulas will treated with seton placement by silk thread

Locations
Country Name City State
Pakistan Services hospital Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary fistula healing fistula healing, complete healing of wound with no external opening of fistula 8 to 12 weeks
Secondary Fistula recurrence Recurrence of perianal fistula after treatment 6 months
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