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

Phase 3
Not Enrolling
Colorectal Carcinoma

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Trial Information

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

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

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.

Inclusion Criteria:

- Patients diagnosed to have colorectal carcinoma at all locations except transverse

- Informed consent available

Exclusion Criteria:

- Patients with tumor >6 cm in size, or with tumor infiltration to adjacent organs on

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival and disease-free survival

Principal Investigator

Ka Lau Leung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

September 1993

Completion Date:

October 2008

Related Keywords:

  • Colorectal Carcinoma
  • Colorectal carcinoma
  • Rectal carcinoma
  • Laparoscopy
  • Laparoscopic surgery
  • Open surgery
  • Randomized trial
  • Carcinoma
  • Colorectal Neoplasms