Monahan, M., Kaur, M., Roberts, T. et al. (111 more authors) (2024) Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5–8-year follow-up of the ROCSS randomized controlled trial. British Journal of Surgery, 111 (8). znae159. ISSN 0007-1323
Abstract
Background The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5–8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall–specific quality of life score.
Methods Eligible participants from original UK centres were identified. The primary outcome (abdominal wall–specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients’ original allocation, even if the patient was aware of their treatment.
Results Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (−2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04).
Conclusions ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall–specific quality of life 5–8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. |
Keywords: | Humans; Surgical Mesh; Cost-Benefit Analysis; Quality of Life; Female; Male; Incisional Hernia; Follow-Up Studies; Surgical Stomas; Middle Aged; Aged |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Academic Unit of Medical Education (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 28 Jan 2025 12:08 |
Last Modified: | 28 Jan 2025 12:08 |
Published Version: | https://doi.org/10.1093/bjs/znae159 |
Status: | Published |
Publisher: | Oxford University Press (OUP) |
Refereed: | Yes |
Identification Number: | 10.1093/bjs/znae159 |
Related URLs: | |
Sustainable Development Goals: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:222390 |