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A randomised controlled trial of laparoscopic surgery for colorectal cancer
DOI 10.1186/ISRCTN74883561
ClinicalTrials.gov identifier NCT00003354
EudraCT number
Public title A randomised controlled trial of laparoscopic surgery for colorectal cancer
Scientific title
Serial number at source G9328312
Study hypothesis 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
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Colorectal cancer
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/07/1996
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 1000. Closed to recruitment - in follow-up
Interventions Laparoscopic surgery vs conventional surgery
Primary outcome measure(s) 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
Secondary outcome measure(s) 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
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 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
Contact name Professor  PJ  Guillou
  Address Academic Unit of Surgery
Clinical Sciences Building
St James's University Hospital
  City/town Leeds
  Zip/Postcode LS9 7TF
  Country United Kingdom
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 06/04/2000
Last edited 02/12/2010
Date ISRCTN assigned 06/04/2000
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