Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer - Full Text View

Purpose

The purpose of this study is to compare the short and long term outcomes of people who have colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a laparoscopic assisted approach (keyhole surgery). This study involves 37 credentialled surgeons in 20 approved hospitals across Australasia and during the recruitment period (Jan 1998 to March 2005) 601 patients were recruited into the ALCCaS Trial.

Condition	Intervention
Colonic Neoplasms	Procedure: Laparoscopic-assisted colectomy Procedure: Conventional open colectomy

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults

Further study details as provided by The Queen Elizabeth Hospital:

Primary Outcome Measures:

Disease-free interval
Three-year survival
Five-year survival

Secondary Outcome Measures:

30-day mortality
Postoperative pain
Paralytic ileus
Early morbidity
Late morbidity
Recovery
Transfusion requirement
Cost effectiveness
Quality of Life outcomes

Estimated Enrollment:	600
Study Start Date:	January 1998
Estimated Study Completion Date:	March 2010

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid colon
18 years of age or older
Able to give informed consent
Must be able to participate in follow-up examinations
Must not have prohibitive scars or adhesions from previous abdominal surgery

Exclusion Criteria:

Advanced local disease, defined as >8cm in diameter or extensive infiltration
Any previous or current malignant tumour with the previous 5 years (except superficial squamous or basal cell skin carcinoma or in situ cervical cancer)
ASA 4
ASA 5
Associated gastrointestinal disease
Dukes D disease
Emergency presentation
Massive bleeding
Morbid obesity
Pregnancy
Rectal cancer
Transverse colon cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202111

Locations


Australia, New South Wales
	Concord Hospital
	Concord, New South Wales, Australia, 2137
	Royal North Shore Hospital & Community Health Service
	St Leonards, New South Wales, Australia, 2065
	Royal Prince Alfred Hospital
	Camperdown, New South Wales, Australia, 2050
	St George Hospital
	Kogarah, New South Wales, Australia, 2217

Australia, Queensland
	Royal Brisbane Hospital
	Brisbane, Queensland, Australia, 4000
	North West Brisbane Private Hospital
	Everton Park, Queensland, Australia, 4053
	Greenslopes Private Hospital
	Greenslopes, Queensland, Australia, 4120
	Holy Spirit Northside Private Hospital
	Chermside, Queensland, Australia, 4032
	North West Brisbane Private Hospital
	Everton Park, Queensland, Australia, 4053
	Wesley Hospital
	Auchenflower, Queensland, Australia, 4066

Australia, South Australia
	The Queen Elizabeth Hospital
	Woodville South, South Australia, Australia, 5011
	Royal Adelaide Hospital
	Adelaide, South Australia, Australia, 5000
	Lyell McEwin Health Service
	Elizabeth Vale, South Australia, Australia, 5112
	Calvary Health Care Adelaide Inc.
	North Adelaide, South Australia, Australia, 5006

Australia, Victoria
	Ballarat Base Hospital
	Ballarat, Victoria, Australia, 3350
	Cabrini Institute
	Malvern, Victoria, Australia, 3144
	Monash Medical Centre
	Clayton, Victoria, Australia, 3168
	Western Health
	Footscray, Victoria, Australia, 3011

Australia, Western Australia
	Fremantle Hospital
	Fremantle, Western Australia, Australia, 6160

New Zealand
	Christchurch Hospital
	Christchurch, New Zealand
	Auckland Hospital
	Auckland, New Zealand

Sponsors and Collaborators

The Queen Elizabeth Hospital

National Health and Medical Research Council, Australia

Health Research Council of New Zealand

Ethicon Endo-Surgery

Investigators


Study Director:	Peter J Hewett, MBBS, FRACS	The Queen Elizabeth Hospital

Principal Investigator:	Andrew RL Stevenson, MBBS, FRACS	Royal Brisbane Hospital

Principal Investigator:	Michael J Solomon, FRACS, MSc	Royal Prince Alfred Medical Centre

More Information

Study ID Numbers:	83449871, NH&MRC ID 207815, NH&MRC ID 349381
First Received:	September 12, 2005
Last Updated:	October 16, 2006
ClinicalTrials.gov Identifier:	NCT00202111
Health Authority:	New Zealand: Health Research Council

Keywords provided by The Queen Elizabeth Hospital:

Clinical Trial

Colonic Neoplasms

Laparoscopic Surgery

Morbidity

Port Site Metastasis

Disease-Free Survival

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Neoplasm Metastasis

Gastrointestinal Neoplasms

Intestinal Diseases

Colonic Neoplasms

Intestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	The Queen Elizabeth Hospital National Health and Medical Research Council, Australia Health Research Council of New Zealand Ethicon Endo-Surgery
Information provided by:	The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:	NCT00202111