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

Anorectal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01913249
• Other study ID #: 2013/581(REK)
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2013
• Last updated: April 17, 2018
• Start date: September 2013
• Est. completion date: April 17, 2018

Study information

• Verified date: September 2013
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 17, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• LIFT
Ligation of intersphincteric fistula tract

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet	Hamar

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

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