To investigate the changes in fistula healing and quality of life after hyperbaric oxygen therapy in patients with Crohn's disease, and to assess the feasibility and safety of the treatment in these patients.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fistula closure, defined as the absence of complaints and/or the absence of an
external orifice at physical examination at week 14, 32 and 48.
Secondary outcome
- Response/remission of co-existing perianal fistulas measured by PDAI
(perianal disease activity index) and FDA (fistula drainage assessment)
- Patient reported outcomes (PROs: EQ-5D-5L, IBDQ, FIQL, FSFI, decision regret
scale)
- (Changes in) use of concomitant medication within the course of the study (58
weeks)
- Re-interventions for both luminal as well as perianal disease within the
course of the study (58 weeks)
- Percentages of and reasons for refusal to participate (in) or finish the
study, if available
- Adverse events during HBO and follow-up
Background summary
The presence of a rectovaginal fistula (RVF) in female patients with Crohn*s
disease (CD) is associated with debilitating symptoms (e.g. vaginal passage of
stool and gas) that can have a large impact on health and quality of life.
Medical treatment is only successful in 40% of cases, and surgical options are
limited. Hyperbaric oxygen therapy (HBO) has been proposed as an effective
adjunctive therapy in (fistulising) CD and inflammatory bowel disease in
general, but the effect on rectovaginal fistulas has not yet been studied.
Study objective
To investigate the changes in fistula healing and quality of life after
hyperbaric oxygen therapy in patients with Crohn's disease, and to assess the
feasibility and safety of the treatment in these patients.
Study design
Prospective, interventional co-hort study with long-term follow-up (1 year).
Intervention
30 session of hyperbaric oxygen therapy at 2.4/2.5 atmosphere.
Study burden and risks
Burden: all patients will need to undergo 30 sessions of hyperbaric oxygen
treatment (6 weeks, 5 times a week, 110 minutes per session) at 2.4/2.5
atmosphere absolute. As a consequence they have a limited risk to suffer from
barotraumas of the ears and sinuses. This risk is about 2-3%. [1] [2] There is
a also very small risk (0.02-0.3%) of acute cerebral oxygen toxicity. [3] [4]
Extensive involvement of a hyperbaric physician will exclude substantial risks
for patients during hyperbaric exposure.
Apart from the quality-of-life questionnaires there are no other study
procedures (such as assessment of fistula healing through physical examination)
that are extra for this study, as they are also done in standard care. There is
no risk involving the patient reported outcomes (questionnaires).
Benefits: Patients could potentially benefit from this treatment in terms of
improved health and quality of life and resolution or decreased activity
(discharge) of rectovaginal fistulas.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Confirmed diagnosis Crohn*s disease as specified in the guidelines by the European Crohn*s and Colitis Organisation
- One or more rectovaginal fistula(s), defined as:
o Patient history typical for rectovaginal fistula (complaints of passage of flatus or stool per vagina), and/or
o Fistula orifice in mucosa of vagina visible during physical examination
- Current treatment regimen has been stable for at least six weeks (i.e. no starting of antibiotics, surgical intervention other than seton placement or removal, addition of immunosuppressants or dosage changes of biologicals)
- > 18 years
- Written informed consent
Exclusion criteria
- Unfit for hyperbaric oxygen therapy as assessed by the hyperbaric physician
- Language barrier
- Unable to give informed consent
- Vaginal fistula other than rectovaginal, such as enterovaginal fistulas
- Presence of fluid collection/abscess related to RVF that needs to be surgically drained
Design
Recruitment
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 |
|---|---|
| CCMO | NL67017.018.18 |