Effect of tailored, intensive prehabilitation for risky lifestyles before ventral hernia repair on postoperative outcomes, health, and costs – study protocol for a randomised controlled trial (STRONG-Hernia)
(2025) In PLoS ONE 20(5 May).- Abstract
Background A substantial untapped potential for risk reduction may be fulfilled by applying intensive lifestyle interventions targeting the co-existing risky lifestyle factors Smoking, Nutrition (both malnutrition and obesity), risky Alcohol intake, and Physical inactivity (SNAP) before surgery. This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost-effectiveness in short and long term in participants undergoing ventral hernia repair. An interview study will be nested within the randomised trial. Methods The study is a multicenter, parallel-group, superiority randomised clinical trial. A total of 400 adult participants undergoing ventral... (More)
Background A substantial untapped potential for risk reduction may be fulfilled by applying intensive lifestyle interventions targeting the co-existing risky lifestyle factors Smoking, Nutrition (both malnutrition and obesity), risky Alcohol intake, and Physical inactivity (SNAP) before surgery. This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost-effectiveness in short and long term in participants undergoing ventral hernia repair. An interview study will be nested within the randomised trial. Methods The study is a multicenter, parallel-group, superiority randomised clinical trial. A total of 400 adult participants undergoing ventral hernia repair with ≥1 SNAP factor will be allocated to the individually tailored STRONG programme or standard care. The STRONG programme is initiated at least four weeks prior to surgery and consists of six sessions. It is delivered as one session a week, approximately, and includes patient education, motivational, and pharmaceutical supports. The primary outcome is postoperative complications requiring treatment within 30 days. Secondary outcomes address other surgical outcomes, changes in lifestyle, health, and cost-effectiveness. Follow-up takes place after 6 weeks (the end of intervention), at surgery, and 30 days, 90 days, and 6 months after surgery, respectively. Long-term data on health and costs will be obtained from nationwide registries after two years. Eligible trial participants will be invited to a semi-structured interview study at baseline. Their reflections on the STRONG programme and the choice of participating in the trial or not will be explored. Discussion Many patients have multiple SNAP factors adding to the risk of complications related to surgery. As these are modifiable, prehabilitation may be an area with great potential for risk reduction. Nevertheless, no well-acknowledged and evidence-based strategies exist in the preoperative period. The STRONG programme is tailored specifically to the individual patient’s preidentified needs including up to all five common risky SNAP factors and may tap into the large unused potential for risk reduction. Overall, the study will add important new knowledge on the effect of individually tailored prehabilitation on complications and other important outcomes in elective surgery, and also clarify if this intervention will have long-lasting implications.
(Less)
- author
- Skovbo Jensen, Sofie Anne Marie ; Lauridsen, Susanne Vahr ; Fonnes, Siv ; Rosenberg, Jacob and Tønnesen, Hanne LU
- organization
- publishing date
- 2025-05
- type
- Contribution to journal
- publication status
- published
- subject
- in
- PLoS ONE
- volume
- 20
- issue
- 5 May
- article number
- e0324002
- publisher
- Public Library of Science (PLoS)
- external identifiers
-
- pmid:40435308
- scopus:105006679900
- ISSN
- 1932-6203
- DOI
- 10.1371/journal.pone.0324002
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © 2025 Jensen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
- id
- 56d57148-c65e-4b6a-bc9d-1208d0559bb1
- date added to LUP
- 2025-08-06 15:39:11
- date last changed
- 2025-08-06 19:46:15
@article{56d57148-c65e-4b6a-bc9d-1208d0559bb1,
abstract = {{<p>Background A substantial untapped potential for risk reduction may be fulfilled by applying intensive lifestyle interventions targeting the co-existing risky lifestyle factors Smoking, Nutrition (both malnutrition and obesity), risky Alcohol intake, and Physical inactivity (SNAP) before surgery. This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost-effectiveness in short and long term in participants undergoing ventral hernia repair. An interview study will be nested within the randomised trial. Methods The study is a multicenter, parallel-group, superiority randomised clinical trial. A total of 400 adult participants undergoing ventral hernia repair with ≥1 SNAP factor will be allocated to the individually tailored STRONG programme or standard care. The STRONG programme is initiated at least four weeks prior to surgery and consists of six sessions. It is delivered as one session a week, approximately, and includes patient education, motivational, and pharmaceutical supports. The primary outcome is postoperative complications requiring treatment within 30 days. Secondary outcomes address other surgical outcomes, changes in lifestyle, health, and cost-effectiveness. Follow-up takes place after 6 weeks (the end of intervention), at surgery, and 30 days, 90 days, and 6 months after surgery, respectively. Long-term data on health and costs will be obtained from nationwide registries after two years. Eligible trial participants will be invited to a semi-structured interview study at baseline. Their reflections on the STRONG programme and the choice of participating in the trial or not will be explored. Discussion Many patients have multiple SNAP factors adding to the risk of complications related to surgery. As these are modifiable, prehabilitation may be an area with great potential for risk reduction. Nevertheless, no well-acknowledged and evidence-based strategies exist in the preoperative period. The STRONG programme is tailored specifically to the individual patient’s preidentified needs including up to all five common risky SNAP factors and may tap into the large unused potential for risk reduction. Overall, the study will add important new knowledge on the effect of individually tailored prehabilitation on complications and other important outcomes in elective surgery, and also clarify if this intervention will have long-lasting implications.</p>}},
author = {{Skovbo Jensen, Sofie Anne Marie and Lauridsen, Susanne Vahr and Fonnes, Siv and Rosenberg, Jacob and Tønnesen, Hanne}},
issn = {{1932-6203}},
language = {{eng}},
number = {{5 May}},
publisher = {{Public Library of Science (PLoS)}},
series = {{PLoS ONE}},
title = {{Effect of tailored, intensive prehabilitation for risky lifestyles before ventral hernia repair on postoperative outcomes, health, and costs – study protocol for a randomised controlled trial (STRONG-Hernia)}},
url = {{http://dx.doi.org/10.1371/journal.pone.0324002}},
doi = {{10.1371/journal.pone.0324002}},
volume = {{20}},
year = {{2025}},
}