Alexandra Poinas, Noémie Périard, Solène Schirr-Bonnans, Jean-Benoit Hardouin, Riche Valery-Pierre, Odile Cormerais, Michel Guérineau, Guy Valancogne, Hamy Antoine, Mehdi Ouaissi, Yannick Tourreau, Jeremie H Lefevre, Amar Abdelli, Emeric Abet, Jean-Michel Balon, Bridoux Valérie, Dumont Frédéric, June Fortin, Alexandra Jobert, Meurette Guillaume, Duchalais Emilie
Nantes University, CHU Nantes, Inserm,Clinical Investigation Centre CIC1413, Nantes, France.
Nantes University, CHU Nantes, Digestive Surgery Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif-IMAD), Nantes, France.
Colorectal Dis. 2025 Mar;27(3):e70045. doi: 10.1111/codi.70045.
Bowel dysfunction following sphincter-preserving rectal resection for cancer, commonly referred to as low anterior resection syndrome (LARS), significantly impacts patients' quality of life. Preventing this condition is essential for healthcare teams. Postoperative pelvic floor rehabilitation, including anal biofeedback therapy, has shown potential in alleviating established LARS symptoms. This trial aims to evaluate the effectiveness of pelvic floor rehabilitation prior to bowel continuity restoration in preventing LARS in patients undergoing sphincter-preserving rectal resection for cancer.
CONTICARE is a national multicentre randomized trial. Patients who have undergone total mesorectal excision with sphincter preservation and a defunctioning stoma (n = 174; 87 per arm) will be randomly assigned to either the rehabilitation or control group before stoma closure. The rehabilitation group will receive systematic pelvic floor rehabilitation, comprising four sessions before and six sessions after stoma closure, following a standardized approach. The control group will receive standard follow-up care, which includes symptom-based therapy after ileostomy closure. The primary outcome measure will be the severity of LARS, assessed using the dedicated LARS score at 6 months. Comparisons of faecal incontinence symptoms, quality of life and complications related to biofeedback therapy will also be evaluated at 6 weeks, 6 months and 1 year between the two groups.
Pelvic floor rehabilitation has the potential to enhance symptom management and quality of life for patients following rectal resection by preventing LARS. The combination of anal exercises and biofeedback therapy, which has been extensively studied without reported adverse effects, suggests that the anticipated benefits outweigh any potential risks.
Registration number NCT03876561, first published on 15 March 2019.
gov.
保肛直肠癌切除术后的肠道功能障碍，通常称为低位前切除综合征（LARS），会显著影响患者的生活质量。预防这种情况对医疗团队至关重要。术后盆底康复，包括肛门生物反馈疗法，已显示出缓解已出现的LARS症状的潜力。本试验旨在评估在恢复肠道连续性之前进行盆底康复对预防接受保肛直肠癌切除术患者发生LARS的有效性。
CONTICARE是一项全国多中心随机试验。接受了保留括约肌的全直肠系膜切除术和去功能化造口术的患者（n = 174；每组87例）将在造口关闭前随机分配至康复组或对照组。康复组将采用标准化方法接受系统的盆底康复，包括造口关闭前4次和关闭后6次治疗。对照组将接受标准的随访护理，包括回肠造口关闭后的症状性治疗。主要结局指标将是LARS的严重程度，在6个月时使用专门的LARS评分进行评估。两组还将在6周、6个月和1年时评估大便失禁症状、生活质量以及与生物反馈疗法相关的并发症。
盆底康复有可能通过预防LARS来改善直肠癌切除术后患者的症状管理和生活质量。肛门运动和生物反馈疗法的联合应用已得到广泛研究且未报告有不良反应，这表明预期益处超过任何潜在风险。
注册号NCT03876561，于2019年3月15日首次发表。
ClinicalTrials.gov
