Anterior resection syndrome: a randomized clinical trial of a 5-HT3 receptor antagonist (ramosetron) in male patients with rectal cancer
Autor: | D W Lee, Kwan-Hwa Park, Y H Kwon, Juhun Park, Myung Ah Lee, Sohyun Jeong, Seung Bum Ryoo, Mokwon Kim, Sung-Hyun Moon |
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Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty Randomization Colorectal cancer medicine.medical_treatment Population Ramosetron law.invention 03 medical and health sciences Ileostomy chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans Serotonin 5-HT3 Receptor Antagonists Adverse effect education education.field_of_study Proctectomy business.industry Rectal Neoplasms Rectum Syndrome Middle Aged medicine.disease Treatment Outcome chemistry 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Surgery Benzimidazoles business |
Zdroj: | The British journal of surgery. 108(6) |
ISSN: | 1365-2168 |
Popis: | Background 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. Methods 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. Results 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. Conclusion Ramosetron could be safe and feasible for male patients with ARS. Trial registration number NCT02869984 (http://www.clinicaltrials.gov). |
Databáze: | OpenAIRE |
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