Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Colorectal Carcinoma Clinical Trial

Official title:

Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485316
• Other study ID #: CRE-8118
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2007
• Last updated: March 30, 2009
• Start date: September 1993
• Est. completion date: October 2008

Study information

• Verified date: March 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Informed consent available

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Procedure:
• Laparoscopic assisted resection of colorectal carcinoma

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival and disease-free survival
Secondary	Operative time
Secondary	Blood loss
Secondary	Postoperative analgesic requirements
Secondary	Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
Secondary	Time to walk independently
Secondary	Duration of hospital stay
Secondary	Morbidity and mortality
Secondary	Direct cost