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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults
Secondary ID [1] 0 0
NH&MRC ID 207815
Secondary ID [2] 0 0
83449871
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Laparoscopic-assisted colectomy
Treatment: Surgery - Conventional open colectomy

Treatment: Surgery: Laparoscopic-assisted colectomy


Treatment: Surgery: Conventional open colectomy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free interval
Timepoint [1] 0 0
Primary outcome [2] 0 0
Three-year survival
Timepoint [2] 0 0
Primary outcome [3] 0 0
Five-year survival
Timepoint [3] 0 0
Secondary outcome [1] 0 0
30-day mortality
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Postoperative pain
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Paralytic ileus
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Early morbidity
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Late morbidity
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Recovery
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Transfusion requirement
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Cost effectiveness
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Quality of Life outcomes
Timepoint [9] 0 0

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal North Shore Hospital & Community Health Service - St Leonards
Recruitment hospital [5] 0 0
Wesley Hospital - Auchenflower
Recruitment hospital [6] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [7] 0 0
Holy Spirit Northside Private Hospital - Chermside
Recruitment hospital [8] 0 0
North West Brisbane Private Hospital - Everton Park
Recruitment hospital [9] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Lyell McEwin Health Service - Elizabeth Vale
Recruitment hospital [12] 0 0
Calvary Health Care Adelaide Inc. - North Adelaide
Recruitment hospital [13] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [14] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [15] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [16] 0 0
Western Health - Footscray
Recruitment hospital [17] 0 0
Cabrini Institute - Malvern
Recruitment hospital [18] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2137 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4000 - Brisbane
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment postcode(s) [8] 0 0
4053 - Everton Park
Recruitment postcode(s) [9] 0 0
4120 - Greenslopes
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 0 0
5006 - North Adelaide
Recruitment postcode(s) [13] 0 0
5011 - Woodville South
Recruitment postcode(s) [14] 0 0
3350 - Ballarat
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3011 - Footscray
Recruitment postcode(s) [17] 0 0
3144 - Malvern
Recruitment postcode(s) [18] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Health Research Council, New Zealand
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Ethicon Endo-Surgery
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00202111
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter J Hewett, MBBS, FRACS
Address 0 0
The Queen Elizabeth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00202111