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临床试验/NCT02036112
NCT02036112Unknown不适用

Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年8月1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
60
试验地点
1
主要终点
The perioperative morbidity

研究概览

简要总结

An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.

详细描述

We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left

. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tumor within 5 cm of the anal verge or with a very narrow pelvis
  • T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
  • Absence of distant metastases
  • Absence of intestinal obstruction

排除标准

  • T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
  • With distant metastases
  • With intestinal obstruction
  • Pregnancy or lactation
  • Allergic constitution to heterogeneous protein
  • With operation contraindication

研究组 & 干预措施

Individual ELAPE

Experimental

Patients will receive Individual ELAPE technique

干预措施: Individual ELAPE (Procedure)

Conventional ELAPE

Experimental

Patients with advanced lower rectal cancer will receive conventional EALPE technique

干预措施: conventional ELAPE (Procedure)

结局指标

主要结局

The perioperative morbidity

时间窗: three years

Sexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation

次要结局

  • Three years survival postoperatively(three years)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Jun Wang

Professor

Beijing Chao Yang Hospital

研究点 (1)

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