A randomised controlled trial of laparoscopic surgery for colorectal cancer

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer; Malignant neoplasm of other or ill-defined digestive organs

• Registration Number: ISRCTN74883561
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17634484 3 year results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20013936 results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20629110 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-06
• Study Completion: 2009-12-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pathological endpoints (circumferential, longitudinal and high-tie mesenteric resection margins)<br> 2. 30-day operative mortality<br> 3. Disease-free survival, overall survival and local recurrence rates at 3 years<br> 4. Local and distal recurrence rates, quality of life and cost effectiveness<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease-free and overall survival at 5 years<br> 2. Port-site and wound-site recurrence<br> 3. Complication rates<br> 4. Quality of life and cost effectiveness<br> 5. Blood transfusion requirements<br> 6. Loco-regional, anastomotic and distant metastases<br>