Department of Anaesthesiology/Hyperbaric Medicine, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.
Department of Surgery, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.
BJS Open. 2021 May 7;5(3). doi: 10.1093/bjsopen/zrab042.
Positive effects of hyperbaric oxygen (HBO) on perianal fistulas in Crohn's disease (CD) have been described, but the effect on rectovaginal fistulas (RVFs) has not yet been studied. The aim was to investigate the efficacy, safety and feasibility of HBO in patients with RVF in CD.
In this prospective study, consecutive CD patients between November 2018 and February 2020 presenting with RVF at the outpatient fistula clinic of the Amsterdam University Medical Centre were included and selected to receive treatment with 30 daily HBO sessions, if fistulas were actively draining and any concomitant treatment regimen was stable at least 6 weeks prior to start of HBO. Patients with a stoma were excluded. The primary endpoint was clinical closure at 3-month follow-up, defined as cessation of complaints and/or closure of the external orifice if visible at baseline. Secondary outcomes were improvement of concomitant perianal fistulas as measured by the perianal disease activity index (PDAI) and fistula drainage assessment (FDA), as well as improvement in patient-reported outcomes (visual analogue scale (VAS), inflammatory bowel disease questionnaire (IBDQ), faecal incontinence quality of life scale (FIQL) and female sexual functioning index (FSFI)) at 3-month follow-up.
Out of 14 eligible patients, nine patients (median age 50 years) were treated, all of whom had previously had one or more unsuccessful medical and/or surgical treatments for their RVF. Clinical closure occurred in none of the patients at 3-month follow-up. There was no improvement in PDAI and patient-reported outcomes (VAS, IBDQ, FIQL and FSFI). Two patients had concomitant perianal fistulas; using FDA, one patient had a clinical response and one patient was in clinical remission 3 months after HBO. There were two treatment-related adverse events during HBO concerning claustrophobia and fatigue. Furthermore, two patients had a surgical intervention due to RVF and two patients were treated with antibiotics for a urinary tract infection during follow-up. One patient had a dose reduction of ustekinumab because of decreased luminal complaints.
Treatment with HBO was feasible, but in this therapy-refractory cohort without deviating ostomy no clinical closure of RVF or improvement in quality of life was seen 3 months after HBO. Treatment with HBO alone in this specific group of patients therefore appears to be ineffective.
高压氧 (HBO) 对克罗恩病 (CD) 肛旁瘘管的积极影响已有描述，但对直肠阴道瘘 (RVF) 的影响尚未研究。目的是研究 HBO 对 CD 合并 RVF 患者的疗效、安全性和可行性。
本前瞻性研究纳入了 2018 年 11 月至 2020 年 2 月在阿姆斯特丹大学医学中心门诊瘘管诊所就诊的 RVF 合并 CD 患者，这些患者的 RVF 正在引流，且在 HBO 开始前至少 6 周其伴随治疗方案稳定。排除有造口的患者。主要终点是 3 个月随访时的临床愈合，定义为停止抱怨和/或基线时可见的外部开口闭合。次要终点是通过肛周疾病活动指数 (PDAI) 和瘘管引流评估 (FDA) 评估的同时存在的肛周瘘管的改善，以及 3 个月随访时患者报告的结果（视觉模拟量表 (VAS)、炎症性肠病问卷 (IBDQ)、粪便失禁生活质量量表 (FIQL) 和女性性功能指数 (FSFI)）的改善。
在 14 名符合条件的患者中，9 名患者（中位年龄 50 岁）接受了治疗，他们都曾接受过一次或多次 RVF 的不成功的药物和/或手术治疗。在 3 个月的随访中，没有患者出现临床愈合。PDAI 和患者报告的结果（VAS、IBDQ、FIQL 和 FSFI）均无改善。2 名患者同时存在肛周瘘管；使用 FDA，1 名患者有临床反应，1 名患者在 HBO 后 3 个月处于临床缓解期。在 HBO 期间有 2 例与治疗相关的不良事件，与幽闭恐惧症和疲劳有关。此外，在随访期间，2 名患者因 RVF 进行了手术干预，2 名患者因尿路感染接受了抗生素治疗。1 名患者因腔道抱怨减少而减少了乌司奴单抗的剂量。
HBO 治疗是可行的，但在这个没有改变造口术的治疗难治性队列中，HBO 治疗后 3 个月并未观察到 RVF 的临床愈合或生活质量的改善。因此，在这组特定患者中，单独使用 HBO 似乎无效。
