Mari Giulio, Maggioni Dario, Costanzi Andrea, Miranda Angelo, Rigamonti Luca, Crippa Jacopo, Magistro Carmelo, Di Lernia Stefano, Forgione Antonello, Carnevali Pietro, Nichelatti Michele, Carzaniga Pierluigi, Valenti Francesco, Rovagnati Marco, Berselli Mattia, Cocozza Eugenio, Livraghi Lorenzo, Origi Matteo, Scandroglio Ildo, Roscio Francesco, De Luca Antonio, Ferrari Giovanni, Pugliese Raffaele
Dipartimento di Chirurgia Generale, AO Vimercate, Ospedale di Desio, Vimercate, Italy.
Dipartimento di Chirurgia Generale e Videolaparoscopia, Ospedale Niguarda Ca' Granda di Milano, Milan, Italy.
Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.
The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial.
METHODS/DESIGN: The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients.
The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function.
ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.
在腹腔镜直肠前切除术并全直肠系膜切除术中，动脉结扎的位置会影响泌尿生殖功能、肠道功能、肿瘤学结局及吻合口漏的发生率。在直肠手术中，于肠系膜下动脉起始处结扎或保留左结肠动脉的操作均广泛应用。本研究的目的是在一项对照随机试验中，比较腹腔镜直肠前切除术并全直肠系膜切除术中，肠系膜下动脉高位或低位结扎时泌尿生殖功能障碍、吻合口漏及肿瘤学结局的发生率。
方法/设计：HIGHLOW研究是一项多中心随机对照试验，在该试验中，患者在腹腔镜直肠前切除术并全直肠系膜切除治疗直肠癌时被随机分配至肠系膜下动脉高位或低位结扎组。纳入标准为中低位直肠癌（距肛缘0至12厘米）、美国麻醉医师协会评分I、II或III级、体重指数低于30。主要终点指标是术后泌尿生殖功能障碍的发生率。次要终点指标是两组中吻合口漏的发生率。总共200例患者（每组100例）在估计泌尿生殖功能障碍发生率有20%的差异时将有84.45%的把握度。每组100例患者的样本量有可能发现显著差异（α = 0.05，β = 0.1555）。考虑到估计有5%的脱落率，所需样本量为212例患者。
HIGHLOW试验是一项随机多中心对照试验，将为腹腔镜直肠前切除术并全直肠系膜切除术中动脉结扎水平在更好地保留术后泌尿生殖功能方面的优点提供证据。
ClinicalTrials.gov标识符：NCT02153801 方案注册回执 2014年5月29日。
