Ulrich Alexis B, Seiler Christoph, Rahbari Nuh, Weitz Jürgen, Büchler Markus W
Department of General Surgery, Visceral Surgery, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Dis Colon Rectum. 2009 Mar;52(3):412-8. doi: 10.1007/DCR.0b013e318197e1b1.
The necessity of a protective stoma in patients undergoing low anterior resection with total mesorectal excision for primary rectal cancer is discussed controversially. We conducted a randomized, controlled, pilot-study to evaluate the need for diverting ileostomy in patients undergoing low anterior resection [NCT00457327].
Forty patients after elective sphincter-saving low anterior resection were eligible for intraoperative randomization. The primary objective of this trial was to demonstrate similar risks after the resection with both techniques. A priori stopping rules were defined for early termination of the trial.
Between July 4, 2006 and March 12, 2007, a total of 41 patients were screened and 34 patients were randomized. Eighteen patients were randomized to the stoma group and 16 patients to the nonstoma group The symptomatic anastomotic leakage rate was significantly higher in the nonstoma group (37.5 percent) than in the stoma group (5.5 percent, P = 0.02). In all six cases in the nonstoma group, reoperations were necessary. The study was stopped after 34 patients were included. A meta-analysis of the available data confirmed the value of a protective ostomy for patients undergoing low anterior resection.
The data demonstrate a high risk for patients undergoing low anterior resection without diverting ileostomy.
对于原发性直肠癌患者行低位前切除术加全直肠系膜切除时是否需要保护性造口存在争议。我们开展了一项随机对照试验性研究，以评估低位前切除术患者行回肠转流造口术的必要性[NCT00457327]。
40例行选择性保留括约肌低位前切除术的患者符合术中随机分组条件。该试验的主要目的是证明两种技术切除术后的风险相似。定义了先验性停止规则以提前终止试验。
2006年7月4日至2007年3月12日期间，共筛查41例患者，34例患者被随机分组。18例患者被随机分入造口组，16例患者被分入非造口组。非造口组的症状性吻合口漏发生率（37.5%）显著高于造口组（5.5%，P = 0.02）。非造口组的所有6例患者均需再次手术。纳入34例患者后该研究停止。对现有数据的荟萃分析证实了保护性造口对低位前切除术患者的价值。
数据表明，未行回肠转流造口术的低位前切除术患者风险较高。
