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Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 3

Conditions

Colorectal Carcinoma

Treatments

Procedure: Laparoscopic assisted resection of colorectal carcinoma

Study type

Interventional

Funder types

Other

Identifiers

NCT00485316
CRE-8118

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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