deltatrials
Completed PHASE3 INTERVENTIONAL NCT00485316

Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

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

Sponsor: Chinese University of Hong Kong

Updated 6 times since 2017 Last updated: Mar 30, 2009 Started: Sep 30, 1993 Primary completion: Oct 31, 2008 Completion: Oct 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Colorectal Carcinoma and is currently completed. Chinese University of Hong Kong leads this study, which shows 6 recorded versions since 1993 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Sep 1993

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Chinese University of Hong Kong
Data source: Chinese University of Hong Kong

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations