ITA trial: A randomized controlled trial of ligation of the intersphincteric fistula tract versus transanal advancement flap repair

Withdrawn

• Conditions: Anal fistula; Fistula-in-ano; 10002112; 10017998

• Registration Number: NL-OMON37916
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients with a transsphincteric fistula of cryptoglandular origin, passing through the upper or middle third of the external anal sphincter.;Age: 18-75 years.

Exclusion Criteria

Patients with a fistula of cryptoglandular origin other than described in the inclusion criteria;Patients with a transsphincteric fistula of cryptoglandular origin, passing through the upper or middle third of the external anal sphincter, in whom the fistula is associated with intersphincteric horseshoe extension;Patients with a rectovaginal fistula ;Patients with inflammatory bowel disease (Crohn*s disease and/or Colitis Ulcerosa)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Surgery time.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Postoperative pain-recovery<br /><br>- Postoperative complications<br /><br>- Hospital stay and resumption of work<br /><br>- Impairment of fecal continence<br /><br>- Quality of life<br /><br>- Cost-effectiveness from a healthcare and societal perspective</p><br>