EnROL
Conventional versus laparoscopic surgery for colorectal cancer within an enhanced programme.
Chief Investigator: Mr Robin Kennedy
Sponsor: University of Oxford & North West London Hospitals NHS Trust
Sponsor: University of Oxford & North West London Hospitals NHS Trust
The aim of the trial is to compare two different approaches to surgery for bowel cancer, within an enhanced recovery programme.
STUDY STATUS
Open to recruitment.
Target recruitment: 266
Current recruitment: 70 patients (February 2010)
Active sites: 6 (February 2010)
STUDY SCHEMA
INCLUSION CRITERIA
- Diagnosis of colorectal cancer
- Suitable for elective resection following planned admission
- >= 18 years of age
- Written informed consent given
EXCLUSION CRITERIA
- Acute intestinal obstruction
- Unplanned admission to hospital
- Unsuitability for epidural insertion - determined pre-randomisation
- Pregnant
- Unsuitable for laparoscopic resection as conversion to open surgery is likely
STUDY OBJECTIVES
Primary:
- Post-operative physical fatigue
Secondary
- Post-operative stay
- 30 day and in-hospital complications
- 30 day re-admission & re-operation rates
- Assessment of health economics using cost-effectiveness & cost utility
- Patient reported and functional outcomes
- Cosmetic assessments
eCRFs
EnROL is the first trial run by OCTO that is using web-based submission of data (eCRFs) including randomisation.KEY DATES
Recruitment started: July 2008EnROL Trial Office (OCTO)
General Enquiries:Tel: +44 (0)1865 617 017/617 086 fax: +44 (0)1865 617 010
Email: enrol@octo-oxford.org.uk
Website: www.octo-oxford.org.uk
Last updated: 02/03/10 09:36 (octoeditor)
