NCT01913249

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

April 19, 2018

Status Verified

September 1, 2013

Enrollment Period

4.6 years

First QC Date

July 29, 2013

Last Update Submit

April 17, 2018

Conditions

Anorectal Fistula

Keywords

Anorectal fistulaLIFTSeton

Outcome Measures

Primary Outcomes (2)

  • Recurrence rate

    Recurrence or non-healing of anal fistula one year after LIFT surgery

    1 year

  • Complication

    Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Seton through fistula 6 months prior to LIFT

Procedure: LIFT

Control

ACTIVE COMPARATOR

Seton through fistula 3 weeks prior to LIFT surgery

Procedure: LIFT

Interventions

LIFTPROCEDURE

Ligation of intersphincteric fistula tract

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Innlandet

Hamar, Norway

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 1, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 17, 2018

Last Updated

April 19, 2018

Record last verified: 2013-09

Locations

NO(1)