With this study we hope to improve the closure rate of perianal Crohn*s fistulas.
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 of patients with closed fistulas
(based on an evaluated MRI-score) after 18 months.
Secondary outcome
Secondary outcomes are disease activity by Perianal Disease Activity Index
(PDAI), quality of life and costs.
Background summary
Currently, the treatment of Crohn's patients with perianal fistulas
predominantly exist of anti-TNF medication. Even though it is a very expensive
drug, its efficiency has never been directly compared to surgical closure of
the perianal fistula. Based on the available literature, closure of fistulas is
expected in 50% of patients in the surgical closure group compared to 25% in
the anti-TNF group.
Study objective
With this study we hope to improve the closure rate of perianal Crohn*s
fistulas.
Study design
Multicenter patient preference model: patients with a preference for one of
both treatment strategies will be treated accordingly, whereas those patients
without a distinct preference will be randomized in the usual way.
Intervention
Group I: anti-TNF (seton for ± 6 weeks under anti-TNF medication in combination
with immunomodulator, followed by seton removal with continuation of anti-TNF
medication for ± 1 year)
Group II: Surgical closure (seton drainage , followed by advancement plasty
(AF) or ligation of the intersphincteric tract (LIFT) procedure after ± 8-10
weeks, with removal of the seton under anti-TNF in combination with
immunomodulator for ± 4 months)
Study burden and risks
All patients will receive one of the standard treatment approaches that are
currently used for Crohn's fistulas, therefore no additional risk is associated
with participating to the trial. All effort has been performed to ensure most
optimal treatment, according to best available evidence and current guidelines
(including drug monitoring). Since there is no experimental study-arm, there
are no additional risks associated with participation. During the study, the
medical staff and trial nurses will monitor the necessity of surgical
interventions and hospitalisations. After 18 months all patients will undergo a
MRI to score the fistula. Secondary outcome parameters (number of draining
fistulas and PDAI score) will be assessed during visits to the outpatient
clinic at baseline and at intervals of 6 months for the duration of the study
period. Health related quality of life will be measured by the EQ-5D and IBDQ
questionnaires, both will be mailed to the patients every 3 months. Data on
out-of-hospital care, and productivity losses resulting from sick-leave will be
retrieved from tailored patient questionnaires.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
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;- Use of Anti-TNF medication for more than 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 with a contra-indication for anti-TNF ;- 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002064-15-NL |
| CCMO | NL66176.018.18 |
| OMON | NL-OMON20965 |