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临床试验/NCT00949273
NCT00949273Unknown不适用

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer

Beijing Chao Yang Hospital7 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
7
主要终点
postoperative complications

研究概览

简要总结

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

详细描述

Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence.

Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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 6 cm of the anal verge, or with very narrow pelvis
  • T3-T4 as determined by preoperative MRI 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 MRI or endorectal ultrasonography examination
  • with distant metastases
  • with intestinal obstruction
  • pregnancy or lactation
  • allergic constitution to heterogeneous protein
  • with operation contraindication
  • with mental disorder

结局指标

主要结局

postoperative complications

时间窗: 08/01/2011

次要结局

  • 3-years overall survival(08/01/2013)

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 and Head of General Surgery

Beijing Chao Yang Hospital

研究点 (7)

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