PDF(Pubmed)
Abstract：
BACKGROUND: Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT).
METHODS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).
CONCLUSIONS: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.
BACKGROUND: Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.
METHODS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).
CONCLUSIONS: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.
BACKGROUND: Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.
摘要：
背景：低位前切除综合征（LARS）是一种令人痛苦的疾病，影响约25-80％的直肠癌手术后患者。LARS的特点是使人衰弱的肠功能障碍症状，包括大便失禁,紧急排便,排便频率增加.尽管生物反馈疗法已证明在改善术后直肠控制方面有效，研究结果没有达到预期。最近的研究强调，刺激阴部会阴神经比单独的生物反馈对增强盆底肌肉功能具有更好的影响。因此，本研究旨在通过一项随机对照试验(RCT),评估生物反馈与经皮阴部神经电刺激(B-PEPNS)联合治疗LARS患者的疗效.
方法：在这个双臂多中心RCT中，242名直肠手术后LARS的参与者将被随机分配接受B-PEPNS（干预组）或生物反馈（对照组）。超过4周,每位参与者将接受20次治疗.主要结果将是LARS得分。次要结果将是肛门直肠测压和盆底肌肌电图检查结果以及欧洲癌症研究和治疗组织生活质量问卷-结肠直肠29（EORTCQLQ-CR29）评分。数据将在基线时收集，干预后（1个月），并随访（6个月）。
结论：我们预计这项研究将进一步证明B-PEPNS在减轻直肠癌术后患者LARS症状和提高生活质量方面的有效性。
背景：中国临床试验注册ChiCTR2300078101。2023年11月28日注册。
方法：在这个双臂多中心RCT中，242名直肠手术后LARS的参与者将被随机分配接受B-PEPNS（干预组）或生物反馈（对照组）。超过4周,每位参与者将接受20次治疗.主要结果将是LARS得分。次要结果将是肛门直肠测压和盆底肌肌电图检查结果以及欧洲癌症研究和治疗组织生活质量问卷-结肠直肠29（EORTCQLQ-CR29）评分。数据将在基线时收集，干预后（1个月），并随访（6个月）。
结论：我们预计这项研究将进一步证明B-PEPNS在减轻直肠癌术后患者LARS症状和提高生活质量方面的有效性。
背景：中国临床试验注册ChiCTR2300078101。2023年11月28日注册。
