Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.
Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Trials. 2020 Jan 28;21(1):112. doi: 10.1186/s13063-019-4043-7.
After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment.
The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes.
The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial.
Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.
低位前切除术（LAR）后，多达 90%的患者会出现肛门直肠功能障碍。特别是粪便失禁对患者的身体、心理、社会和情感功能有重大影响，也对荷兰国家医疗保健预算造成影响，每位患者每年花费超过 2000 欧元。目前尚无标准化的治疗方法可以帮助这些患者。目前常见的治疗方法侧重于症状缓解，包括生活方式建议和使用容积性药物或止泻药物的药物治疗。另一种可能性是盆底康复（PFR），这是一般粪便失禁最重要的治疗方法之一，成功率为 50-80%。目前尚无强有力的证据支持 LAR 后使用 PFR。本研究旨在证明与标准治疗相比，PFR 对保肛手术后直肠癌患者的粪便失禁、生活质量和成本有有益的影响。
FORCE 试验是一项多中心、双臂、随机临床试验。所有接受 LAR 的患者均从参与医院招募，并随机分为标准治疗或标准化 PFR 方案。应随机分配 128 名患者。无法实现最佳盲法。分层将按变量块（性别和额外放疗）进行。主要终点是 Wexner 失禁评分；次要终点是与健康相关和与粪便失禁相关的生活质量和成本效益。基线测量在随机分组前进行。主要终点在干预开始后 3 个月测量，1 年随访以进行可持续性研究。
本研究的结果可能会极大地改善 LAR 后粪便失禁或肛门直肠功能障碍患者的术后护理。本节介绍了组织这项试验时所做的决策。
荷兰试验注册，NTR5469，于 2015 年 9 月 3 日注册。FORCE 试验协议 V18，2019 年 9 月 19 日。赞助商 Radboud 大学医学中心，奈梅亨。
