HOT-REVA trial: Hyperbaric Oxygen Therapy for the treatment of RectoVaginal fistulas in Crohn*s disease.

HOT-REVA trial: Hyperbaric Oxygen Therapy for the treatment of RectoVaginal fistulas in Crohn*s disease. - HOT-REVA trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46287

Enrollment

Registered

2018-10-19

Start date

2018-11-01

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

opening between rectum/anus and vagina in Crohn's disease Rectovaginal fistulas in Crohn's disease

Interventions

30 session of hyperbaric oxygen therapy at 2.4/2.5 atmosphere.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)