Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969591
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Quan Wang, First Hospital of Jilin University

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: fast-track surgery Other: conventional postoperative surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
Study Start Date : January 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  2. Postoperative days [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  3. First flatus time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  4. First defecation time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]
  5. solid diet time [ Time Frame: with the first 30 days(plus or minus 3days) after surgery ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Quan Wang, Deputy Director of General Surgery, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT01969591     History of Changes
Other Study ID Numbers: 2013-171
2013-171
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by Quan Wang, First Hospital of Jilin University:
Fast track surgery, Laparoscopic surgery, colorectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases