Currently, there is no guideline for the treatment of perianal Crohn's fistulas. the aim of this study, in which surgical strategies (seton drainage and surgical closure with advancement plasty/LIFT) will be compared to medical treatment. We…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is the number patients needing fistula-related
re-intervention(s).
Secondary outcome
Secondary outcomes are the number of patients with closed fistulas and the
percentage of closed fistulas (based on MRI) after 18 months, and the number of
antibiotic courses that was required during treatment. Furthermore we evaluate
the Perianal Disease Activity Index, quality of life, and costs.
Background summary
Crohn*s disease is a chronic disease that typically affects young adults. In
The Netherlands only, there are 20,000 patients of whom approximately 20% have
perianal fistulas. Perianal fistulising disease is associated with local pain,
discharge, and considerable morbidity rates (including recurrent abcessess and
sphincter destruction). This results in a negative impact on quality of life
with sick-leave and an enormous impact on health care resources.
There are several treatment options for complex high fistulas with one internal
opening. Until last decade, the most frequently used treatment approach has
been surgical seton placement for chronic drainage of the fistula which
maintains patency of the tract and eliminates the accumulation of pus which
prevents the recurrent formation of tracts and abscesses, One disadvantage of
this technique is that the fistula will not close with the seton in situ and
that the patient has a chronic trans-anal drainage. Another option is surgical
closure of the internal fistula opening by creating an advancement plasty or
performing a LIFT. Unfortunately re-interventions were required in almost 50%
of patients. Nowadays most patients receive treatment with anti-TNF agents. A
randomized controleld trial demonstrated a significant increase in fistula
closure with infliximab when compared to placebo treatment. However only 60% of
patients were responsive to medical treatment and after cessation of medication
there was re-opening of the fistulas in 50%. Thereby treatment with anti-TNF is
expensive (>25,000 Euros pp/year) and its efficiency has been never compared
to surgical strategies.
Study objective
Currently, there is no guideline for the treatment of perianal Crohn's
fistulas. the aim of this study, in which surgical strategies (seton drainage
and surgical closure with advancement plasty/LIFT) will be compared to medical
treatment. We hope to provide treatment consensus for daily practice. Thereby
we will also assess the quality of life and cost-effectivenes.
Study design
Multicenter randomised controlled trial
Intervention
Group I: chronic seton (seton drainage for 1 year) and 6MP
Group II: anti-TNF (seton for 6 weeks under anti-TNF, followed by seton removal
with continuation of medication for 1 year) and 6MP
Group III: advancement plasty or LIFT (in patients with a transsfincteric
fistula) (seton drainage under anti-TNF. After 8-10 weeks, surgical closure
with advancement plasty under anti-TNF for 4 months) and 6MP
Study burden and risks
The study compares three accepted management strategies. So there is no
experimental treatment group.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- * 18 years;- Written informed consent;- High tract (intersphincteric, transsphincteric, suprasphincteric) perianal fistula located in the upper ;two-thirds of the external sphincter ;- Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not ;have to be taken into account;- Both new fistulas or recurrent active fistula (defined as any producing fistula)
Exclusion criteria
- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum);- Anorectal stenosis (defined as the impossibility to introduce a proctoscope);- Submucosal fistulas & low intersphincteric fistulas (lower one-third of external sphincter);- Rectovaginal fistula;- Multiple internal openings;- Seton in situ for more than 3 months;- Use of Anti-TNF medication during last 3 months;- Previous Anti-TNF medication without any effect on perianal fistulas;- Previously demonstrated allergy for anti-TNF medication. If this allergy only concerns the chimeric ;monoclonal mouse-antibody infliximab, the patient could be randomised for adalumimab;- Patients with a stoma;- Immunocompromised patients (i.e. haematological malignancies, HIV/AIDS, bone marrow ;transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, ;chemotherapy, dialysis, solid organ transplant and long term immunosuppressant use such as ;corticosteroids in patients with rheumatoid arthritis);- Life expectancy < 2 years;- The inability of reading/understanding and filling in the questionnaires;- Dementia or altered mental status that would prohibit the understanding and giving of informed ;consent
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002932-25-NL |
| CCMO | NL44901.018.13 |