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临床试验/NCT03520088
NCT03520088Unknown不适用

PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS

Corporacion Parc Tauli2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision

研究概览

简要总结

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per group.

详细描述

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. The sample to be included will be 90 patients, 45 per group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The analysis of the results will be blind for the investigator

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age greater (or equal) to 18 years
  • Diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy)
  • Candidate for neoadjuvant (chemoradiotherapy).
  • Scheduled laparoscopic radical TME surgery carried out by colorectal surgeons;
  • ASA I, II or III;
  • Informed consent present.

排除标准

  • Under 18 years old;
  • Not Candidate for neoadjuvant (chemoradiotherapy);
  • Emergency surgery;
  • Recurrent neoplasms
  • Patient with a history of infra-abdominal, or pelvic surgery of the prostate, or radiotherapy prior to the current process;
  • Patients with severe sexual dysfunction and neurological alterations before surgery
  • Patients with neurogenic bladder before surgery.
  • Not to sign the informed consent

研究组 & 干预措施

Inferior mesenteric Vein dissection

Experimental

To improve and preserve the rectal nerve in the total mesorectal excision, its starts the dissection from the inferior mesenteric vein to the inferior mesenteric artery and through the pelvis

干预措施: Inferior mesenteric Vein dissection (Procedure)

Inferior mesenteric Artery dissection

Active Comparator

As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis

干预措施: Inferior mesenteric Artery dissection (Procedure)

结局指标

主要结局

Changes in sexual dysfunction pre- and post-Total Mesorectal Excision

时间窗: 1 week before surgery and 12 months post-surgery

Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5

次要结局

未报告次要终点

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Pallisera-Lloveras

md, PhD

Corporacion Parc Tauli

研究点 (2)

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