To compare the Anal Fistula Plug with the fistulotomy in the treatment of low perianal fistula.
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. Continence (questionnaires and manometry)
2. Post-operative pain
Secondary outcome
1. Anorectal fistula closure rate
2. Morbidity
3. Quality of life
Background summary
Low transsphincteric fistulas comprising less than 1/3 of the external
sphincter complex are commonly treated by fistulotomy (lay-open) with a good
success rate. During surgery the fistula tract is identified and divided over a
probe. Perianal fistulas where the fistula tract runs low through the sphincter
complex are also divided. As a consequence part of the sphinctercomplex is
divided. Some surgeons feel that every fibre divided is one to many, as this
could lead to incontinence at later age. No long term outcome has ever been
reported on the development of incontinence of patients who have undergone a
fistulotomy.
Recently Armstrong reported on 46 patients treated with the anal fistula plug,
a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa.
Their prospective series of 46 patients with high perianal fistula treated with
the Anal Fistula Plug showed promising results.
Study objective
To compare the Anal Fistula Plug with the fistulotomy in the treatment of low
perianal fistula.
Study design
Prospective randomised controlled double blinded trial
Intervention
Installation of the anal fistula plug
Study burden and risks
Burden:
Filling out four questionnaires before and after surgery
Pre- and postoperatively anorectal manometry is performed
Risk:
no risk
Benefit:
No benefit
postbus 22660
1100DD Amsterdam
Nederland
postbus 22660
1100DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
low anorectal fistula of cryptoglandular origin (intersphincteric and transsphincteric, lower 1/3 of the sphinctercomplex 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 | NL17707.018.07 |