AimPelvic radiotherapy is limited by dose‐dependent toxicity to surrounding organs. The aim of this prospective study was to evaluate the efficacy and safety of intrarectal formalin treatment for radiotherapy‐induced haemorrhagic proctopathy (RHP) at the Royal Marsden Hospital.MethodAdult patients were enrolled. Haemoglobin was evaluated before and after formalin treatment. Antiplatelet and/or anticoagulation treatment and administration of transfusion were recorded. The interval between completion of radiotherapy and the first intrarectal 5% formalin treatment was assessed and the dose of radiotherapy was evaluated. Clinical assessment of the frequency and amount of rectal bleeding (rectal bleeding score 1–6) and endoscopic appearance (grade 0–3) were classified. Complications were recorded.ResultsNineteen patients were enrolled, comprising 13 men (68%) and 6 women. The mean age was 75 ± 9 years. The median time between completion of radiotherapy and the first treatment was 20 months [interquartile range (IQR) 15 months] and the median dose of radiotherapy was 68 Gy (IQR 14 Gy). Thirty‐two procedures were performed (average 1.7 per patient). In total, 9/19 (47%) patients were receiving anticoagulation and/or antiplatelet medication and 5/19 (26%) received transfusion prior to treatment. The mean value of serum haemoglobin before the first treatment was 110 ± 18 g/L and afterwards it was 123 ± 16 g/L (p = 0.022). The median rectal bleeding score before the first treatment was 6 (IQR 0) and afterwards 2 (IQR 1–4; p < 0.001), while the median endoscopy score on the day of first treatment was 3 (IQR 0) compared with 1 (IQR 1–2) on the day of the last treatment 1 (p < 0.001). One female patient with a persistent rectal ulcer that eventually healed (18 months of healing) subsequently developed rectovaginal fistula (complication rate 1/19, 5%).ConclusionsTreatment with intrarectal formalin in RHP is effective and safe.

中文翻译：

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直肠内福尔马林治疗出血性放射性直肠病：疗效和安全性

目的盆腔放疗受到周围器官剂量依赖性毒性的限制。这项前瞻性研究的目的是评估皇家马斯登医院直肠内福尔马林治疗放疗引起的出血性直肠病 (RHP) 的有效性和安全性。方法 纳入成年患者。在福尔马林治疗之前和之后评估血红蛋白。记录抗血小板和/或抗凝治疗以及输血给药。评估放疗完成与首次直肠内5%福尔马林治疗之间的间隔，并评估放疗剂量。对直肠出血频率和量（直肠出血评分 1-6）和内镜外观（0-3 级）的临床评估进行分类。记录并发症。结果 19 名患者入组，其中 13 名男性 (68%) 和 6 名女性。平均年龄为 75 ± 9 岁。完成放疗与首次治疗之间的中位时间为 20 个月 [四分位距 (IQR) 15 个月]，放疗的中位剂量为 68 Gy (IQR 14 Gy)。进行了 32 次手术（平均每位患者 1.7 次）。总共有 9/19 (47%) 的患者正在接受抗凝和/或抗血小板药物治疗，5/19 (26%) 的患者在治疗前接受了输血。首次治疗前血清血红蛋白平均值为110±18g/L，治疗后为123±16g/L（p= 0.022）。首次治疗前直肠出血评分中位数为 6 (IQR 0)，治疗后为 2 (IQR 1-4；p< 0.001)，而第一次治疗当天的中位内窥镜评分为 3 (IQR 0)，而最后一次治疗当天的中位内镜评分为 1 (IQR 1–2) 1 (p< 0.001）。一名持续性直肠溃疡最终愈合（愈合 18 个月）的女性患者随后出现直肠阴道瘘（并发症发生率 1/19，5%）。结论 RHP 直肠内福尔马林治疗有效且安全。