Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

April 17, 2018 updated by: Sykehuset Innlandet HF

Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.

The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Norway
      • Hamar, Norway
        • Sykehuset Innlandet

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20 and 65 years

  • Complex anal fistula defined as

    • anterior fistulas in women
    • branched fistulas
    • fistulas in patients with anal incontinence
    • fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.

Exclusion Criteria:

  • Crohn's disease in the rectum
  • Previous LIFT surgery on same side
  • Patient already treated with seton > 3 weeks
  • Not able or willing to sign informed consent

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Seton through fistula 6 months prior to LIFT
Procedure: LIFT
Ligation of intersphincteric fistula tract
Active Comparator: Control
Seton through fistula 3 weeks prior to LIFT surgery
Procedure: LIFT
Ligation of intersphincteric fistula tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 1 year
Recurrence or non-healing of anal fistula one year after LIFT surgery
1 year
Complication
Time Frame: 1 year
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
1 year

Collaborators and Investigators

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

Sponsor

Sykehuset Innlandet HF

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

September 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/581(REK)

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.

Clinical Trials on Anorectal Fistula

Clinical Trials on LIFT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe