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

October 21, 2013 updated by: Quan Wang
To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: with the first 30 days(plus or minus 3days) after surgery
with the first 30 days(plus or minus 3days) after surgery
Postoperative days
Time Frame: with the first 30 days(plus or minus 3days) after surgery
with the first 30 days(plus or minus 3days) after surgery
First flatus time
Time Frame: with the first 30 days(plus or minus 3days) after surgery
with the first 30 days(plus or minus 3days) after surgery
First defecation time
Time Frame: with the first 30 days(plus or minus 3days) after surgery
with the first 30 days(plus or minus 3days) after surgery
solid diet time
Time Frame: with the first 30 days(plus or minus 3days) after surgery
with the first 30 days(plus or minus 3days) after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quan Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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