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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: fast-track surgery; Other: conventional postoperative 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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Other: convontional postoperative care; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Quan Wang

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Fast track surgery, Laparoscopic surgery, colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2013-171 (Other Identifier: Barbara Ann Karmanos Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No