Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1993-09-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Colorectal Carcinoma

Keywords

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Colorectal carcinoma Rectal carcinoma Laparoscopy Laparoscopic surgery Open surgery Randomized trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Laparoscopic assisted resection of colorectal carcinoma

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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The Chinese University of Hong Kong

Principal Investigators

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Ka Lau Leung, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong SAR, , China

Site Status

Countries

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China

References

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Ng SS, Lee JF, Yiu RY, Li JC, Hon SS, Mak TW, Ngo DK, Leung WW, Leung KL. Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial. Surg Endosc. 2014 Jan;28(1):297-306. doi: 10.1007/s00464-013-3187-x. Epub 2013 Sep 7.

Reference Type DERIVED

PMID: 24013470 (View on PubMed)

Li JC, Leung KL, Ng SS, Liu SY, Lee JF, Hon SS. Laparoscopic-assisted versus open resection of right-sided colonic cancer--a prospective randomized controlled trial. Int J Colorectal Dis. 2012 Jan;27(1):95-102. doi: 10.1007/s00384-011-1294-5. Epub 2011 Aug 23.