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临床试验/NCT01969591
NCT01969591已完成不适用

Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery

Quan Wang0 个研究点目标入组 70 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
Length of hospital stay

研究概览

简要总结

To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.

详细描述

Method: This study is a blinded randomized trial. 70 patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≤75 years
  • Good nutrition
  • no systemic infection
  • Elective laparoscopic surgery

排除标准

  • Age >75 years
  • Malnutrition or an organ system infection
  • Associated with obstruction, bleeding, emergency surgery or surgical intervention
  • Tumor with extensive metastasis
  • Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
  • Previous history of abdominal surgery
  • Patient had previously undergone gastrostomy

结局指标

主要结局

Length of hospital stay

时间窗: with the first 30 days(plus or minus 3days) after surgery

Postoperative days

时间窗: with the first 30 days(plus or minus 3days) after surgery

First flatus time

时间窗: with the first 30 days(plus or minus 3days) after surgery

First defecation time

时间窗: with the first 30 days(plus or minus 3days) after surgery

solid diet time

时间窗: with the first 30 days(plus or minus 3days) after surgery

次要结局

  • Analgesics(with the first 30 days(plus or minus 3days) after surgery)
  • CRP (mg/L)(with the first 30 days(plus or minus 3days) after surgery)
  • Complications:anastomotic leakage,intestinal obstruction,wound infection(one year)

研究者

发起方
Quan Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Quan Wang

Deputy Director of General Surgery

The First Hospital of Jilin University

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