Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Phase 3

Completed

• Conditions: Colorectal Carcinoma

• Registration Number: NCT00485316
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The aim of the investigators' randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colorectal carcinoma.

Detailed Description

Since the introduction of laparoscopic cholecystectomy in 1987, laparoscopic surgery has been attempted and applied to many surgical operations. Surgeons in Hong Kong began to perform laparoscopic surgery for colorectal carcinoma in early 1992. Early reports of laparoscopic surgery for colorectal carcinoma from Hong Kong and worldwide suggested better short-term clinical outcomes when compared with open surgery, but there were concerns over port site metastases and adequacy of long-term oncological clearance. Besides, only a few randomized trials thus far have compared laparoscopic-assisted and open surgery for rectal carcinoma.

The aim of our randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colonic and rectal carcinoma.

Patients will undergo different types of surgery according to the location of the tumors: right or extended right hemicolectomy for cecal, ascending colon, or hepatic flexure tumors; left hemicolectomy for descending colon tumors; sigmoid colectomy for sigmoid colon tumors; anterior resection for rectosigmoid or upper rectal tumors; low anterior resection with total mesorectal excision for mid- and low rectal tumors; abdominoperineal resection for very low rectal tumors. Patients will be randomly allocated to laparoscopic assisted or conventional open surgery.

Short-term clinical outcome and long-term survival data will be prospectively recorded and compared between the two treatment arms.

Study Timeline

• Study Start: 1993-09
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-12
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients diagnosed to have colorectal carcinoma at all locations except transverse colon
• Informed consent available

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Exclusion Criteria

• Patients with tumor >6 cm in size, or with tumor infiltration to adjacent organs on imagings
• Patients with previous abdominal surgery near the region of the colorectal surgery
• Patients with intestinal obstruction or perforation
• Patients with recurrent disease
• Patients with synchronous colorectal carcinoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival and disease-free survival

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic requirements
Duration of hospital stay
Direct cost
Blood loss
Operative time
Time to walk independently
Morbidity and mortality
Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China