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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37916
Enrollment
50
Registered
2012-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Anal fistula

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Surgery time.

Secondary

MeasureTime frame
- Postoperative pain-recovery - Postoperative complications - Hospital stay and resumption of work - Impairment of fecal continence - Quality of life - Cost-effectiveness from a healthcare and societal perspective

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)