Journal article
CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer
- Abstract:
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Aim
Excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial.
Methods
CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence.
Conclusion
CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
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- Files:
-
-
(Preview, Version of record, pdf, 2.6MB, Terms of use)
-
- Publisher copy:
- 10.1111/codi.16687
Authors
+ Cancer Research UK
More from this funder
- Funder identifier:
- https://ror.org/054225q67
- Grant:
- RCCFEL-2018\100001
- Publisher:
- Wiley
- Journal:
- Colorectal Disease More from this journal
- Volume:
- 25
- Issue:
- 9
- Pages:
- 1910-1920
- Place of publication:
- England
- Publication date:
- 2023-07-31
- Acceptance date:
- 2023-06-19
- DOI:
- EISSN:
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1463-1318
- ISSN:
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1462-8910
- Pmid:
-
37525408
- Language:
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English
- Keywords:
- Pubs id:
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1499377
- Local pid:
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pubs:1499377
- Deposit date:
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2025-03-05
- ARK identifier:
Terms of use
- Copyright holder:
- Koutoukidis et al
- Copyright date:
- 2023
- Rights statement:
- © 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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