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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: fast-track surgery; Other: conventional postoperative surgery

• Registration Number: NCT01969591
• Lead Sponsor: Quan Wang

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2013-09
• Status Verified: 2013-10
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-21
• Last Update Submitted: 2013-10-21
• Study First Posted: 2013-10-25
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fast-track surgery	fast-track surgery	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.
convontional postoperative care	conventional postoperative surgery	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	with the first 30 days(plus or minus 3days) after surgery
Postoperative days	with the first 30 days(plus or minus 3days) after surgery
First flatus time	with the first 30 days(plus or minus 3days) after surgery
First defecation time	with the first 30 days(plus or minus 3days) after surgery
solid diet time	with the first 30 days(plus or minus 3days) after surgery

Secondary Outcome Measures

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