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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01913249

Enrollment

Registered

2013-08-01

Start date

2013-09-30

Completion date

2018-04-17

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal Fistula

Keywords

Anorectal fistula, LIFT, Seton

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.

Interventions

PROCEDURELIFT

Ligation of intersphincteric fistula tract

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026