直肠癌低位前切除术中选择性去功能造口术（SELSA）：一项前瞻性研究方案，该研究包含一项嵌套随机临床试验，旨在调查全直肠系膜切除术后无造口生存且无严重低位前切除综合征的情况。
SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision.
作者信息
Rutegård Martin, Lindsköld Marcus, Jörgren Fredrik, Landerholm Kalle, Matthiessen Peter, Forsmo Håvard Mjørud, Park Jennifer, Rosenberg Jacob, Schultz Johannes, Seeberg Lars T, Segelman Josefin, Buchwald Pamela
机构信息
Department of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
出版信息
Colorectal Dis. 2025 Feb;27(2):e70009. doi: 10.1111/codi.70009.
AIM
Accumulated data suggest that routine use of defunctioning stoma in low anterior resection for rectal cancer may cause kidney injury, bowel dysfunction and a higher risk of permanent stomas. We aim to study whether avoidance of a diverting stoma in selected patients is safe and reduces adverse consequences.
METHODS
SELSA is a multicentre international prospective observational study nesting an open-label randomized clinical trial. All patients with primary rectal cancer planned for low anterior resection are eligible. Patients operated with curative intent, aged <80 years, with an American Society of Anaesthesiologists' fitness grade I or II, and a low predicted risk of anastomotic leakage are eligible to 1:1 randomization between no defunctioning stoma (experimental arm) or a defunctioning stoma (control arm). The primary outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS score, and permanent stoma rate. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients. Patient inclusion will commence in the autumn of 2024.
CONCLUSION
The SELSA study is investigating a tailored approach to defunctioning stoma use in low anterior resection for rectal cancer in relation to the risk of anastomotic leakage. Our hypothesis is that long-term effects will favour the selective approach, enabling some patients to avoid a defunctioning stoma.
TRIAL REGISTRATION
Swedish Ethical Review Authority approval (2023-04347-01, 2024-02418-02 and 2024-03622-02), Regional Ethics Committee Denmark (H-24014463), and ClinicalTrials.gov (NCT06214988).
目的
累积数据表明，直肠癌低位前切除术常规使用去功能化造口可能会导致肾损伤、肠道功能障碍以及永久性造口风险增加。我们旨在研究在特定患者中避免使用转流造口是否安全并能减少不良后果。
方法
SELSA是一项多中心国际前瞻性观察性研究，其中嵌套了一项开放标签随机临床试验。所有计划接受低位前切除术的原发性直肠癌患者均符合条件。具有治愈意图、年龄<80岁、美国麻醉医师协会身体状况分级为I或II级且吻合口漏预测风险低的患者，有资格按1:1随机分为不使用去功能化造口（试验组）或使用去功能化造口（对照组）。主要结局是无严重低位前切除综合征（LARS）的2年无造口生存率的综合指标。次要结局包括吻合口漏、术后死亡率、再次干预、造口相关并发症、生活质量指标、LARS评分和永久性造口率。为了能够说明任何研究组在主要结局方面的优越性，具有90%的统计效力并假设25%的失访率，我们计划招募212名患者。患者纳入将于2024年秋季开始。
结论
SELSA研究正在调查针对直肠癌低位前切除术中去功能化造口使用的定制方法与吻合口漏风险的关系。我们的假设是长期效果将有利于选择性方法，使一些患者能够避免使用去功能化造口。
试验注册
瑞典伦理审查局批准（2023 - 04347 - 01、2024 - 02418 - 02和2024 - 03622 - 02）、丹麦地区伦理委员会（H - 24014463）以及ClinicalTrials.gov（NCT06214988）。
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