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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00202111
Registration number
NCT00202111
Ethics application status
Date submitted
12/09/2005
Date registered
20/09/2005
Date last updated
17/10/2006
Titles & IDs
Public title
Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer
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Scientific title
Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults
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Secondary ID [1]
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NH&MRC ID 207815
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Secondary ID [2]
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83449871
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free interval
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Three-year survival
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Five-year survival
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [1]
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30-day mortality
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Postoperative pain
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Paralytic ileus
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Early morbidity
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Late morbidity
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Recovery
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Transfusion requirement
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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Cost effectiveness
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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Quality of Life outcomes
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Assessment method [9]
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Timepoint [9]
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/1998
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Concord Hospital - Concord
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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Royal North Shore Hospital & Community Health Service - St Leonards
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Recruitment hospital [5]
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Wesley Hospital - Auchenflower
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Recruitment hospital [6]
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Royal Brisbane Hospital - Brisbane
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Recruitment hospital [7]
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Holy Spirit Northside Private Hospital - Chermside
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Recruitment hospital [8]
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North West Brisbane Private Hospital - Everton Park
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Recruitment hospital [9]
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [10]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [11]
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Lyell McEwin Health Service - Elizabeth Vale
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Recruitment hospital [12]
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Calvary Health Care Adelaide Inc. - North Adelaide
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Recruitment hospital [13]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [14]
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Ballarat Base Hospital - Ballarat
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Recruitment hospital [15]
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Monash Medical Centre - Clayton
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Recruitment hospital [16]
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Western Health - Footscray
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Recruitment hospital [17]
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Cabrini Institute - Malvern
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Recruitment hospital [18]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2137 - Concord
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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4066 - Auchenflower
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Recruitment postcode(s) [6]
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4000 - Brisbane
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Recruitment postcode(s) [7]
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4032 - Chermside
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Recruitment postcode(s) [8]
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4053 - Everton Park
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Recruitment postcode(s) [9]
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4120 - Greenslopes
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Recruitment postcode(s) [10]
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5000 - Adelaide
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Recruitment postcode(s) [11]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [12]
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5006 - North Adelaide
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Recruitment postcode(s) [13]
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5011 - Woodville South
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Recruitment postcode(s) [14]
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3350 - Ballarat
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Recruitment postcode(s) [15]
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3168 - Clayton
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Recruitment postcode(s) [16]
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3011 - Footscray
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Recruitment postcode(s) [17]
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3144 - Malvern
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Recruitment postcode(s) [18]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Queen Elizabeth Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Health Research Council, New Zealand
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Address [2]
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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Ethicon Endo-Surgery
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00202111
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Trial related presentations / publications
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. Allardyce 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. 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. doi: 10.1097/SLA.0b013e31818b7595.
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Public notes
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Contacts
Principal investigator
Name
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Peter J Hewett, MBBS, FRACS
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Address
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The Queen Elizabeth Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00202111
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