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临床试验/NCT02153801
NCT02153801已完成不适用

Sexual Urinary Function in Patients Undergoing Laparoscopic Low Anterior Resection With Total Mesorectal Excision With High Or Low Ligation of the Inferior Mesenteric Artery With Preservation of Left Colic Artery Multicentre Randomized Trial

Niguarda Hospital1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
1
主要终点
Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires

研究概览

简要总结

The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.

详细描述

The level of arterial ligation can affect genito-urinary function (injury to the superior hypogastric plexus), extent (and yield) of lymphadenectomy, distal colonic arterial perfusion (distal colonic arterial perfusion could be deficient due to degenerative disease), sympathic nerve injures. Moreover, colonic stump blood supply together with anastomosis tension are the main factors in developing leaks in rectal surgery and is dependent of the level of ligation. The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric Artery at the origin or preserving the Left Colic Artery by a prospective randomized trial.

Genito-urinary function will be evaluated with IIEF-5, Internation Consultation Incontinence Modular Questionnarie (ICIQ), Female Sexual Function Index (FSFI), International Index of erectile Function (IIEF) questionnaries and uroflowmetric test pre operatively.

Surgery will be as follow:

The following steps are required in all cases, independently of randomization. The first step consist in the opening of the left part of the gastrocolic ligament and the division of the left part of transverse mesocolon. The splenocolic and phrenocolic attachments are then divided, achieving complete dissection of the left colonic angle. The pelvic peritoneum is opened below the sacral promontory and the hypogastric nerves are identified and preserved. The common iliac veins, the genitofemoral nerve, the gonadic vessels, and the left ureter are successively identified and preserved.

For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • middle or low rectal cancer (from 0 to 12 cm from the anal verge), American Society Anesthesiologist (ASA) I II III, Body Mass index (BMI) lower than 30.

排除标准

  • prior surgery on the abdominal aorta,
  • conversion to laparotomy,
  • intraoperative decision for colostomy.

研究组 & 干预措施

Low Inferior Mesenterci Artery Ligation

Active Comparator

The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.

干预措施: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . (Procedure)

High Inferior Mesenterci Artery Ligation

Other

For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.

For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter.

干预措施: During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision . (Procedure)

结局指标

主要结局

Sexual and Urinary Function assessed with with International Prostatic Symptoms Score (IPSS), ICIQ, IIEF, FSFI questionnaires

时间窗: 9 months from laparoscopic RAR + TME

次要结局

  • Incidence of anastomotic leak(1 month from laparoscopic RAR + TME)
  • Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires(9 month from laparoscopic RAR + TME)
  • Urinary Function assessed with Uroflowmetric examination(9 months from laparoscopic RAR + TME)
  • Sexual and Urinary Function assessed with with IPSS ICIQ IIEF FSFI questionnaires(1 month from laparoscopic RAR + TME)
  • Urinary Function assessed with Uroflowmetric examination(1 months from laparoscopic RAR + TME)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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