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

NCT ID: NCT01913249

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-04-17

Brief Summary

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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.

Detailed Description

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Conditions

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Anorectal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Seton through fistula 6 months prior to LIFT

Group Type EXPERIMENTAL

LIFT

Intervention Type PROCEDURE

Ligation of intersphincteric fistula tract

Control

Seton through fistula 3 weeks prior to LIFT surgery

Group Type ACTIVE_COMPARATOR

LIFT

Intervention Type PROCEDURE

Ligation of intersphincteric fistula tract

Interventions

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LIFT

Ligation of intersphincteric fistula tract

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sykehuset Innlandet

Hamar, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2013/581(REK)

Identifier Type: -

Identifier Source: org_study_id

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