Comparison of Prolene Thread Seton Vs Silk Thread Seton f... | NCT03763981

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

NCT03763981

Sponsor

Services Hospital, Lahore

Status

Completed

Last Update Posted

Dec 4, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Perianal Fistula

Interventions

prolene seton treatment
silk seton treatment

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Aug 30, 2018Actual

Completion Date

Aug 30, 2018Actual

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Dec 2, 2018

First Posted Date

Dec 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2018

Last Update Posted Date

Dec 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prolene seton treatment	Procedure	patients with perianal fistulas will treated with seton placement by prolene thread	prolene seton

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmmood Ayyaz, mbbs, fcps	Services Hospital, Lahore	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services hospital		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided