Clinical trial NCT00485316: Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
Official title: Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Carcinoma
Keywords: Colorectal carcinoma
Rectal carcinoma
Laparoscopy
Laparoscopic surgery
Open surgery
Randomized trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-06-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival and disease-free survival
Secondary outcomes:
measure: Operative time
measure: Blood loss
measure: Postoperative analgesic requirements
measure: Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
measure: Time to walk independently
measure: Duration of hospital stay
measure: Morbidity and mortality
measure: Direct cost
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Ka Lau Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.