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ISRCTN
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ISRCTN74883561
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DOI
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10.1186/ISRCTN74883561
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ClinicalTrials.gov identifier
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NCT00003354
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EudraCT number
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Public title
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A randomised controlled trial of laparoscopic surgery for colorectal cancer
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Scientific title
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Acronym
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CLASICC
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Serial number at source
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G9328312
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Study hypothesis
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To determine whether disease-free and overall survival from laparoscopic surgery for colorectal cancer is comparable to that of conventional surgery as assessed by conventional end-points of survival and surrogate end-points of pathological findings
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Colorectal cancer
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Participants - inclusion criteria
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1. Clinical diagnosis of colorectal cancer (unless this occurs in the transverse colon)
2. Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection or abdomino-perineal resection
3. Aged >18 years
4. Give written informed consent
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Participants - exclusion criteria
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1. Adenocarcinoma of the transverse colon
2. Any contraindication to pneumoperitoneum
3. Acute intestinal obstruction
4. Malignancy within previous 5 years (except basal cell carcinoma, in situ carcinoma of cervix or prostate cancer)
5. Synchronous multiple adenocarcinomas
6. If female, be pregnant
7. Associated gastrointestinal disease that requires surgical intervention
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Anticipated start date
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01/07/1996
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000. Closed to recruitment - in follow-up
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Interventions
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Laparoscopic surgery vs conventional surgery
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Primary outcome measure(s)
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1. Pathological endpoints (circumferential, longitudinal and high-tie mesenteric resection margins)
2. 30-day operative mortality
3. Disease-free survival, overall survival and local recurrence rates at 3 years
4. Local and distal recurrence rates, quality of life and cost effectiveness
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Secondary outcome measure(s)
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1. Disease-free and overall survival at 5 years
2. Port-site and wound-site recurrence
3. Complication rates
4. Quality of life and cost effectiveness
5. Blood transfusion requirements
6. Loco-regional, anastomotic and distant metastases
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2005 short-term end points results in http://www.ncbi.nlm.nih.gov/pubmed/158940982
2. 2007 3 year results in http://www.ncbi.nlm.nih.gov/pubmed/17634484
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20013936
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20629110
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Contact name
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Professor
PJ
Guillou
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Address
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Academic Unit of Surgery
Clinical Sciences Building
St James's University Hospital
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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02/12/2010
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Date ISRCTN assigned
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06/04/2000
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