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NCT Number: NCT00485316

Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

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.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital

Hong Kong SAR, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic assisted resection of colorectal carcinoma

Procedure

Primary outcomes

  1. Overall survival and disease-free survival

Secondary outcomes

  1. Operative time

  2. Blood loss

  3. Postoperative analgesic requirements

  4. Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)

  5. Time to walk independently

  6. Duration of hospital stay

  7. Morbidity and mortality

  8. Direct cost

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2007
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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