TATME database
Research type
Research Database
IRAS ID
156930
Contact name
Steven Arnold
Contact email
Research summary
Transanal Total Mesorectal Excision Database
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/0499
Date of REC Opinion
2 Sep 2015
REC opinion
Further Information Favourable Opinion
Data collection arrangements
An operation involving removal or resection of the rectum is commonly used to treat cancerous or inflammatory bowel diseases. This database will record anonymous information about findings, before, during and after surgery, to allow better understanding of which types of surgery are best for different types of patients. Information will be collected as part of usual care, and will not affect a patients individual care. It will only be used in an anonymised way for research and service evaluation. The research database team and the Pelican Cancer foundation will be repsonsible for the storage of information and maintaining the database in line with data protection and Caldicott Guardian principles. No personal or identifiable information will be used for research purposes without further consent and research ethics review being requested. Data will be stored for at least 15 years before being destroyed, as per Pelican Cancer Foundation standards.
Research programme
Patients treated with resection surgery for rectal cancer have a low risk of the cancer returning, but there are some problems which can occur as a result of the usual surgical method (known as 'Total Mesorectal Excision' TME) being used, including the risk of incontinence and sexual dysfunction. A novel surgical approach, Transanal TME (TATME) may reduce the risk of these problems. Having a database to record findings before, during and after the use of TATME surgery will allow surgeons to see if the technique is indeed better. Funding to set-up and maintain the database is being provided by the Pelican Foundation. It is designed to benefit future patients who require surgery after a diagnosis of rectal cancer or severe inflammatory bowel disease. It is proposed to run an international pilot study across 30 centres to collect data on 200 consecutive patients who undergo the surgery between June 2014 and June 2015. Patients will be followed for one year to record information about their health status at 30 days, and the grade of their disease as well as functional assessments (sexual, urinary, bowel) and quality of life.
Research database title
Transanal Total Mesorectal Excision Database
Establishment organisation
Hampshire Hospitals NHS Foundation Trust
Establishment organisation address
Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA