Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer
Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults
3 other identifiers
interventional
600
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1998
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedOctober 17, 2006
February 1, 2006
September 12, 2005
October 16, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Disease-free interval
Three-year survival
Five-year survival
Secondary Outcomes (9)
30-day mortality
Postoperative pain
Paralytic ileus
Early morbidity
Late morbidity
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid colon
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Queen Elizabeth Hospitallead
- National Health and Medical Research Council, Australiacollaborator
- Health Research Council, New Zealandcollaborator
- Ethicon Endo-Surgerycollaborator
Study Sites (20)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Hospital
Concord, New South Wales, 2137, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital & Community Health Service
St Leonards, New South Wales, 2065, Australia
Wesley Hospital
Auchenflower, Queensland, 4066, Australia
Royal Brisbane Hospital
Brisbane, Queensland, 4000, Australia
Holy Spirit Northside Private Hospital
Chermside, Queensland, 4032, Australia
North West Brisbane Private Hospital
Everton Park, Queensland, 4053, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Lyell McEwin Health Service
Elizabeth Vale, South Australia, 5112, Australia
Calvary Health Care Adelaide Inc.
North Adelaide, South Australia, 5006, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Western Health
Footscray, Victoria, 3011, Australia
Cabrini Institute
Malvern, Victoria, 3144, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Related Publications (3)
Bagshaw PF, Allardyce RA, Frampton CM, Frizelle FA, Hewett PJ, McMurrick PJ, Rieger NA, Smith JS, Solomon MJ, Stevenson AR; Australasian Laparoscopic Colon Cancer Study Group. Long-term outcomes of the australasian randomized clinical trial comparing laparoscopic and conventional open surgical treatments for colon cancer: the Australasian Laparoscopic Colon Cancer Study trial. Ann Surg. 2012 Dec;256(6):915-9. doi: 10.1097/SLA.0b013e3182765ff8.
PMID: 23154392DERIVEDAllardyce RA, Bagshaw PF, Frampton CM, Frizelle FA, Hewett PJ, Rieger NA, Smith JS, Solomon MJ, Stevenson AR; Australasian Laparoscopic Colon Cancer Study Group. Australasian Laparoscopic Colon Cancer Study shows that elderly patients may benefit from lower postoperative complication rates following laparoscopic versus open resection. Br J Surg. 2010 Jan;97(1):86-91. doi: 10.1002/bjs.6785.
PMID: 19937975DERIVEDHewett 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. doi: 10.1097/SLA.0b013e31818b7595.
PMID: 18948799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
January 1, 1998
Study Completion
March 1, 2010
Last Updated
October 17, 2006
Record last verified: 2006-02