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Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by The Queen Elizabeth Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
Ethicon Endo-Surgery
Information provided by:
The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:
NCT00202111
First received: September 12, 2005
Last updated: October 16, 2006
Last verified: February 2006
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
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
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
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00202111     History of Changes
Other Study ID Numbers: 83449871, NH&MRC ID 207815, NH&MRC ID 349381
Study First Received: September 12, 2005
Last Updated: October 16, 2006
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

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

ClinicalTrials.gov processed this record on May 23, 2013