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

Colorectal Cancer Clinical Trial

— FTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969591
• Other study ID #: 2013-171
• Secondary ID: 2013-171
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: October 21, 2013
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quan Wang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		with the first 30 days(plus or minus 3days) after surgery
Primary	Postoperative days		with the first 30 days(plus or minus 3days) after surgery
Primary	First flatus time		with the first 30 days(plus or minus 3days) after surgery
Primary	First defecation time		with the first 30 days(plus or minus 3days) after surgery
Primary	solid diet time		with the first 30 days(plus or minus 3days) after surgery
Secondary	Analgesics		with the first 30 days(plus or minus 3days) after surgery
Secondary	CRP (mg/L)		with the first 30 days(plus or minus 3days) after surgery
Secondary	Complications:anastomotic leakage,intestinal obstruction,wound infection		one year