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

Academisch Medisch Centrum0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年6月11日

试验速览

暂无简介。

•- 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

•- 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

发起方