Based on earlier research in IBD patients in general and perianal fistulas in specific, hyperbaric oxygen therapy might be an effective (adjunctive) treatment for rectovaginal fistulas in Crohn's disease.
ID
Bron
Verkorte titel
Aandoening
Crohn's disease, rectovaginal fistulas, inflammatory bowel disease.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical closure of fistula, defined as cessation of complaints, i.e. passage of feces or flatus per vagina, or closure of the external orifice if visible at baseline.
Achtergrond van het onderzoek
The goal of this study is to assess the use of hyperbaric oxygen therapy for rectovaginal fistulas in Crohn's Disease. 10 patients will be recruited through the outpatient fistula clinic in the AMC. Treatment will start directly at the beginning of the study and will last for 6 weeks (= 43 sessions). Patients will be followed until 1 year after treatment, using the earlier mentioned parameters/outcomes.
Doel van het onderzoek
Based on earlier research in IBD patients in general and perianal fistulas in specific, hyperbaric oxygen therapy might be an effective (adjunctive) treatment for rectovaginal fistulas in Crohn's disease.
Onderzoeksopzet
Baseline and week 10, 18, 32 and 58 (i.e. 1, 3 6 and 12 months after 6 weeks = 30 sessions of HBO).
Onderzoeksproduct en/of interventie
30 sessions of hyperbaric oxygen therapy, consisting of 80 minutes of 100% oxygen with 5-minute airbreaks, with a total session time of 110 minutes. The pressure that will be used is 2.4/2.5 atmosphere absolute.
Publiek
Nina CA Lansdorp
Academic Medical Center, Department of Anesthesiology, Room H1-115
Amsterdam 1105 AZ
The Netherlands
+31 20 5665740 / +31 6 30089592
n.lansdorp@amc.nl
Wetenschappelijk
Nina CA Lansdorp
Academic Medical Center, Department of Anesthesiology, Room H1-115
Amsterdam 1105 AZ
The Netherlands
+31 20 5665740 / +31 6 30089592
n.lansdorp@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Confirmed diagnosis Crohn’s disease as specified in the guidelines by the European Crohn’s and Colitis Organisation 17
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6755 |
| NTR-old | NTR7624 |
| CCMO | NL67017.018.18 |
| OMON | NL-OMON46287 |