A randomised controlled trial of laparoscopic surgery for colorectal cancer

ISRCTN	ISRCTN74883561
DOI	https://doi.org/10.1186/ISRCTN74883561
ClinicalTrials.gov (NCT)	NCT00003354
Protocol serial number	G9328312
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr PJ Guillou
Scientific

Academic Unit of Surgery
Clinical Sciences Building
St James's University Hospital
Leeds
LS9 7TF
United Kingdom

Email	not@provided.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of laparoscopic surgery for colorectal cancer
Study acronym	CLASICC
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	Laparoscopic surgery vs conventional surgery
Intervention type	Other
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
Key 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
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	1000
Key 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
Key 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
Date of first enrolment	01/07/1996
Date of final enrolment	31/12/2009

Academic Unit of Surgery

Leeds
LS9 7TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	3 year results	20/07/2007		Yes	No
Results article	results	01/01/2010		Yes	No
Results article	results	01/11/2010		Yes	No
Plain English results			28/10/2021	No	Yes

28/10/2021: Cancer Research UK plain English results link added.