Department of Surgery, Örebro University Hospital, Örebro, Sweden.
Dis Colon Rectum. 2011 Jun;54(6):747-52. doi: 10.1007/DCR.0b013e3182138e79.
Anorectal function is often impaired after low anterior resection of the rectum. Many factors affect the functional outcome and not all are known.
This trial aimed to assess whether a temporary defunctioning stoma affected anorectal function after the patients had been stoma-free for a year.
Multicenter randomized controlled trial.
Twenty-one Swedish hospitals performing surgery for rectal cancer participated.
Patients who had undergone low anterior resection for adenocarcinoma of the rectum were eligible.
Patients were randomly assigned to receive a defunctioning stoma or no stoma.
Anorectal function was evaluated with a questionnaire after patients had been without a stoma for 12 months. Questions pertained to stool frequency, urgency, fragmentation of bowel movements, evacuation difficulties, incontinence, lifestyle alterations, and whether patients would prefer a permanent stoma.
After exclusion of patients in whom stomas became permanent, a total of 181 (90%) of 201 patients answered the questionnaire (90 in the stoma group and 91 in the no-stoma group). The median number of stools was 3 during the day and 0 at night in both groups. Inability to defer defecation for 15 minutes was reported in 35% of patients in the stoma group and 25% in the no stoma group (P = .15). Median scores were the same in each group regarding need for medication, evacuation difficulties, fragmentation of bowel movements, incontinence, and effects on well-being. Two patients (2.2%) in the stoma group and 3 patients (3.3%) in the no-stoma group would have preferred a permanent stoma.
Because this study was an analysis of secondary end points of a randomized trial, no prestudy power calculation was performed.
A defunctioning stoma after low anterior resection did not affect anorectal function evaluated after 1 year. Many patients experienced impaired anorectal function, but nearly all preferred having impaired anorectal function to a permanent stoma.
直肠前切除术后常导致肛门直肠功能受损。许多因素会影响功能结果，而并非所有因素都已明确。
本试验旨在评估低位直肠前切除术后患者造口还纳 1 年后临时性造口对肛门直肠功能的影响。
多中心随机对照试验。
21 家瑞典医院参与直肠肿瘤手术。
入组标准为低位直肠前切除术后腺癌患者。
患者随机分为接受或不接受预防性造口。
患者无造口 12 个月后采用问卷评估肛门直肠功能。问题涉及排便频率、便急、粪便碎片化、排便困难、失禁、生活方式改变，以及患者是否希望永久性造口。
排除造口永久化的患者后，共 201 例患者中的 181 例（90%）（造口组 90 例，无造口组 91 例）回答了问卷。两组日间排便中位数均为 3 次，夜间为 0 次。造口组有 35%的患者无法延迟 15 分钟排便，无造口组为 25%（P =.15）。两组在需要药物治疗、排便困难、粪便碎片化、失禁以及对生活质量的影响方面的评分中位数相同。造口组有 2 例（2.2%）患者和无造口组有 3 例（3.3%）患者希望永久性造口。
由于本研究是一项随机试验的次要终点分析，因此未进行预先研究的功效计算。
低位直肠前切除术后预防性造口不影响 1 年后的肛门直肠功能。许多患者存在肛门直肠功能受损，但几乎所有患者都更愿意接受受损的肛门直肠功能而不是永久性造口。
