NCT03763981

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

July 10, 2018

Last Update Submit

December 2, 2018

Conditions

Perianal Fistula

Outcome Measures

Primary Outcomes (1)

  • fistula healing

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

    8 to 12 weeks

Secondary Outcomes (1)

  • Fistula recurrence

    6 months

Study Arms (2)

prolene seton

ACTIVE COMPARATOR

Prolene thread will be used as seton treatment for perianal fistulas

Procedure: prolene seton treatment

silk seton

ACTIVE COMPARATOR

Silk thread will be used as seton treatment for perianal fistulas

Procedure: silk seton treatment

Interventions

prolene seton treatmentPROCEDURE

patients with perianal fistulas will treated with seton placement by prolene thread

prolene seton
silk seton treatmentPROCEDURE

patients with perianal fistulas will treated with seton placement by silk thread

silk seton

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 10, 2018

First Posted

December 4, 2018

Study Start

September 1, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

PA(1)