Division of Colorectal Surgery, Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Colorectal Cancer Centre, Seoul National University Cancer Hospital, Seoul, Korea.
Br J Surg. 2021 Jun 22;108(6):644-651. doi: 10.1093/bjs/znab071.
No effective treatment exists for anterior resection syndrome (ARS) following sphincter-saving surgery for rectal cancer. This RCT assessed the safety and efficacy of a 5-HT3 receptor antagonist, ramosetron, for ARS.
A single-centre, randomized, controlled, open-label, parallel group trial was conducted. Male patients with ARS 1 month after rectal cancer surgery or ileostomy reversal were enrolled and randomly assigned (1 : 1) to 5 μg of ramosetron (Irribow®) daily or conservative treatment for 4 weeks. Low ARS (LARS) score was calculated after randomization and 4 weeks after treatment. The study was designed as a superiority test with a primary endpoint of the proportion of patients with major LARS between the groups. Primary outcome analysis was based on the modified intention-to-treat population. Safety was assessed by monitoring adverse events during the study.
: A total of 100 patients were randomized to the ramosetron (49 patients) or conservative treatment group (51 patients). Two patients were excluded, and 48 and 50 patients were analysed in the ramosetron and control groups, respectively. The proportion of major LARS after 4 weeks was 58 per cent (28 of 48 patients) in the ramosetron group versus 82 per cent (41 of 50 patients) in the control group, with a difference of 23.7 per cent (95 per cent c.i. 5.58 to 39.98, P = 0.011). There were minor adverse events in five patients, which were hard stool, frequent stool or anal pain. These were not different between the two groups. There were no serious adverse events.
: Ramosetron could be safe and feasible for male patients with ARS.
NCT02869984 (http://www.clinicaltrials.gov).
保肛手术后发生直肠前切除综合征（ARS）尚无有效治疗方法。本 RCT 评估了 5-HT3 受体拮抗剂雷莫司琼治疗 ARS 的安全性和有效性。
开展了一项单中心、随机、对照、开放标签、平行组试验。纳入直肠手术后或肠造口还纳后 1 个月发生 ARS 的男性患者，并按 1:1 随机分配（1：1）接受雷莫司琼（Irribow®）每日 5μg 或保守治疗 4 周。随机分组后和治疗 4 周后计算低 ARS（LARS）评分。该研究设计为优效性检验，主要终点为两组间的主要 LARS 患者比例。主要结局分析基于改良意向治疗人群。研究期间监测不良事件以评估安全性。
共 100 例患者随机分配至雷莫司琼（49 例）或保守治疗组（51 例）。2 例患者被排除，雷莫司琼组和对照组分别有 48 例和 50 例患者纳入分析。雷莫司琼组治疗 4 周后的主要 LARS 比例为 58%（28/48 例），对照组为 82%（41/50 例），差异为 23.7%（95%可信区间 5.58 至 39.98，P=0.011）。两组各有 5 例患者出现轻微不良事件，为硬便、频繁排便或肛门疼痛，但无组间差异。两组均无严重不良事件。
雷莫司琼治疗男性 ARS 安全可行。
NCT02869984（http://www.clinicaltrials.gov）。
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