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Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00485316
Enrollment
Unknown
Registered
2007-06-12
Start date
1993-09-30
Completion date
2008-10-31
Last updated
2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

Keywords

Colorectal carcinoma, Rectal carcinoma, Laparoscopy, Laparoscopic surgery, Open surgery, Randomized trial

Brief 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.

Detailed 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.

Interventions

PROCEDURELaparoscopic assisted resection of colorectal carcinoma

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall survival and disease-free survival

Secondary

MeasureTime frame
Blood loss
Postoperative analgesic requirements
Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
Operative time
Duration of hospital stay
Morbidity and mortality
Direct cost
Time to walk independently

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026