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Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer

This study is ongoing, but not recruiting participants.

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

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

Show detailed description  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

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




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