Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: October 16, 2006 History of Changes

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

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

Show Detailed Description

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

No publications provided by The Queen Elizabeth Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Hewett PJ, Allardyce RA, Bagshaw PF, Frampton CM, Frizelle FA, Rieger NA, Smith JS, Solomon MJ, Stephens JH, Stevenson AR. Short-term outcomes of the Australasian randomized clinical study comparing laparoscopic and conventional open surgical treatments for colon cancer: the ALCCaS trial. Ann Surg. 2008 Nov;248(5):728-38.

Study ID Numbers:	83449871, NH&MRC ID 207815, NH&MRC ID 349381
Study First Received:	September 12, 2005
Last Updated:	October 16, 2006
ClinicalTrials.gov Identifier:	NCT00202111 History of Changes
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
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009