To compare the Anal Fistula Plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain and sick leave.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Anorectal fistula closure rate
2. Continence
Secondary outcome
1. Morbidity
2. Post-operative pain
3. Quality of life
4. Sick leave
Background summary
Low transsfincteric fistulas less than 1/3 of the sphincter complex are easy to
treat by fistulotomy with a good success rate. High transsfincteric fistulas
remain a surgical challenge. Various surgical procedures are available, but all
of these techniques have a disappointing recurrence rate. Recently Armstrong
and colleques reported about a new biologic anal fistula plug, a bioabsorbable
xenograft made of lyophilized porcine intestinal submucosa. A promising result
was achieved in their prospective series of 15 patients treated with the Anal
Fistula Plug.
Study objective
To compare the Anal Fistula Plug with the mucosal flap advancement in the
treatment of high perianal fistula in terms of success rate, continence,
postoperative pain and sick leave.
Study design
Prospective double blinded randomised controlled trial
Intervention
Placement of the anal fistula plug in the tract of the anorectal fistula.
Study burden and risks
burden:
Filling out four questionnaire forms before and after surgery
Risk:
No risk
benefit:
No benefit
postbus 22660
1100DD Amsterdam
Nederland
postbus 22660
1100DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
High anorectal fistula of cryptoglandular origin (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal))
Informed consent
Exclusion criteria
Age<18 years;HIV-positive;Crohn*s disease;No internal opening found during surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13652.018.06 |