To assess the value of the Anal Fistula Plug combined with the infliximab treatment in the treatment of patients with a chronic loose seton due to perianal Crohn*s disease in terms of success rate, continence, quality of life.
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. Quality of life
Background summary
Crohn*s disease is complicated by the development of fistulas in approximately
one third of patients. These fistulas are often refractory to surgery and are
associated with recurrent drainage and sepsis, discomfort and impaired quality
of life. The techniques often used for high perianal fistulas due to Crohn*s
disease are loose-setons, fistulotomy and sometimes mucosal flap advancements
unfortunately with disappointing results. In recent years infliximab
(monoclonal antibody against TNF-alfa) was found to have positive and safe
effect on the outcome of perianal fistula due to Crohn*s disease and is now
widely used. In the literature there are speculations on a combined medical and
surgical approach to asses the problem. Recently Armstrong and colleagues
reported a new biologic Anal Fistula Plug. Armstrong achieved promising results
in a prospective series of 15 patients with cryptoglandular fistula treated
with the Anal Fistula Plug.
Study objective
To assess the value of the Anal Fistula Plug combined with the infliximab
treatment in the treatment of patients with a chronic loose seton due to
perianal Crohn*s disease in terms of success rate, continence, quality of life.
Study design
Prospective randomised controlled double blinded trial
Intervention
insertion of the anal fistula plug
Study burden and risks
Filling out four questionnaire forms before and after surgery
postbus 22660
1100DD Amsterdam
Nederland
postbus 22660
1100DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Crohn*s disease
Infliximab treatment and chronic loose seton drainage > 2 months
High anorectal fistula (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
Cryptoglandular fistula
Age<18 years
HIV-positive
No internal opening found during surgery
Perianal abscesses on preoperative MRI
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 | NL13767.018.06 |