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临床试验/NCT00164879
NCT00164879Unknown3 期

Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
70
试验地点
1
主要终点
The stoma rate in the two groups of patients

研究概览

简要总结

The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients treated by endoscopic stenting followed by elective laparoscopic resection (the 'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided colorectal cancers.

详细描述

In patients who present with obstructing left-sided colorectal cancers, emergency surgery carries a significant morbidity and mortality. Traditionally, most of these patients would receive staged operations (Hartmann's procedure). Temporary stoma is often required due to the edematous bowel wall precluding primary anastomosis as a result of obstruction and the poor pre-morbid status. A second operation is subsequently required to restore bowel continuity. Apart from the expensive hospital costs of the staged operations, the patient's acceptance to the stoma is poor and the social inconvenience associated with the stoma is obvious. Thus, a significant portion of patients would not be suitable for the second operation due to poor health or advanced disease and having to bear the stoma for the remainder of life. Recently, self-expandable metal stents have been used with success in relieving the acute obstruction in patients with obstructing left-sided colorectal cancers. Endoscopic stenting may help to relieve the obstruction, avoid emergency surgery, and allows patients to undergo one-stage elective surgery without the necessity of making a stoma. We propose to evaluate the clinical benefits of using self-expandable metal stents in patients with obstructing left-sided colorectal cancers followed by elective laparoscopic resection and compare its use to immediate emergency surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Consecutive patients with obstructing colorectal cancers, confirmed on water-soluble contrast enema or computed tomography (CT) scan
  • Consented patients

排除标准

  • Patients with peritonitis that required immediate surgical intervention
  • Patients with distal rectal cancers that are not suitable for stenting
  • Moribund patients, unfit for surgery otherwise
  • Pregnancy

结局指标

主要结局

The stoma rate in the two groups of patients

The success rate of relieving obstruction after stent insertion

次要结局

  • Hospital stay
  • Morbidity and mortality rates in the two groups

研究者

申办方类型
Other

研究点 (1)

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