Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202111
Recruitment Status : Unknown
Verified February 2006 by The Queen Elizabeth Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : October 17, 2006
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
Ethicon Endo-Surgery
Information provided by:
The Queen Elizabeth Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Colonic Neoplasms Procedure: Laparoscopic-assisted colectomy Procedure: Conventional open colectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults
Study Start Date : January 1998
Study Completion Date : March 2010

Primary Outcome Measures :
  1. Disease-free interval
  2. Three-year survival
  3. Five-year survival

Secondary Outcome Measures :
  1. 30-day mortality
  2. Postoperative pain
  3. Paralytic ileus
  4. Early morbidity
  5. Late morbidity
  6. Recovery
  7. Transfusion requirement
  8. Cost effectiveness
  9. Quality of Life outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202111

Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Concord Hospital
Concord, New South Wales, Australia, 2137
St George Hospital
Kogarah, New South Wales, Australia, 2217
Royal North Shore Hospital & Community Health Service
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4000
Holy Spirit Northside Private Hospital
Chermside, Queensland, Australia, 4032
North West Brisbane Private Hospital
Everton Park, Queensland, Australia, 4053
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
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
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3350
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Western Health
Footscray, Victoria, Australia, 3011
Cabrini Institute
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
New Zealand
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
The Queen Elizabeth Hospital
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
Ethicon Endo-Surgery
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00202111     History of Changes
Other Study ID Numbers: 83449871
NH&MRC ID 207815
NH&MRC ID 349381
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: February 2006

Keywords provided by The Queen Elizabeth Hospital:
Clinical Trial
Colonic Neoplasms
Laparoscopic Surgery
Port Site Metastasis
Disease-Free Survival

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases