Quality of Life following surgery for recurrent rectal cancer
Research type
Research Study
Full title
The 10Ten study: Quality of Life after Surgery for Recurrent Rectal Cancer
IRAS ID
231535
Contact name
John Jenkins
Contact email
Sponsor organisation
University of Otago
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Recurrent rectal cancer is a cancer of the rectum (last part of the large bowel) which has regrown in the pelvis despite previous surgery to remove it. Recurrent rectal cancer is a deeply unpleasant condition often leading to pain, disability and death. Extensive surgery is sometimes a suitable option to remove the cancerous tumour and can cure the cancer but the post operative quality of life, as a result of the surgery, can be as unpleasant if not worse than in those who chose to not have surgery. This study aims to find out if this is so and if so which patients are more likely to benefit from surgery.\n\nThis study forms the UK arm of an international study based at the University of Otago (New Zealand), research centres are based in New Zealand, Australia, UK, Ireland and USA.\n\nThe 10ten study is looking at the quality of life in patients who choose to have surgery for recurrent rectal cancer and comparing it to the quality of life of those who have recurrent cancer but have chosen to decline surgery. \n\n20 patients will be recruited in each centre - 10 who have surgery and 10 who decline surgery or in whom surgery is not suitable, quality of life outcomes are extrapolated from questionnaires completed by patient. \n\nPrimary objective\nTo compare the QoL (quality of life) and QALY (quality of life years) of people who have extenuative surgery (Massive surgery to remove the pelvic organs up to and including muscle and bone) for Recurrent Rectal Cancer to those who do not have surgery.\n\nSecondary objectives\nTo determine the significance of R-status (completeness of resection) on QoL and QALY.\nTo determine the impact other palliative treatments (e.g., radiotherapy and or chemotherapy) on QoL and QALY.\nTo determine the impact of extent of surgery on QoL and QALY.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0222
Date of REC Opinion
15 Mar 2018
REC opinion
Further Information Favourable Opinion