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STRONG prehabilitation before elective ventral hernia repair: Learnings from recruitment challenges in a randomized
Sofie Anne-Marie Skovbo Jensen1,2, Susanne Vahr Lauridsen1,2,3, Siv Fonnes2
1WHO-CC, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.
Background:
The impact of smoking, nutrition, alcohol, and physical inactivity (SNAP) on the outcome of ventral hernia repair remains underexplored. This trial aimed to evaluate the effect of targeted, intensive lifestyle prehabilitation on postoperative complications.
Methods:
The STRONG-Hernia trial (NCT06611462) was a multicenter, parallel-group, centrally randomized controlled trial at two Danish university hospitals. Adults scheduled for elective ventral hernia repair with ≥1 risky SNAP factor were randomized (1:1) to STRONG prehabilitation or standard care. Prehabilitation comprised six weekly in-hospital sessions of education, motivational, and pharmaceutical support tailored to each patient's SNAP factors. The primary outcome was postoperative complications ≤30 days. Secondary outcomes included lifestyle changes and health-related quality of life (EQ-5D). Final primary outcome assessment and statistical analyses were blinded. Power calculation required inclusion of 2 × 199 patients.
Results:
Between March 2024 to May 2025, 43 patients were randomized with 21 to STRONG prehabilitation and 22 to standard care. Around 75% had one risky lifestyle factor, and 25% had ≥ 2; obesity was most common. Shortly after randomization, two prehabilitation participants were excluded due to no surgery. At end-of-intervention, 13/19 in the prehabilitation group had optimized all risky lifestyles versus 0/22 in the control group (p < 0.01). Three additional participants in each group did not undergo surgery. At 30 days, complications occurred in 3/16 prehabilitation and 4/19 control participants (p = 1.00). EQ-5D VAS remained unchanged in the prehabilitation group from baseline but decreased significantly in the control group (p = 0.03). EQ-5D-5L index changes were similar between groups (p = 0.92). Challenges encountered included outsourcing of patients, insufficient recruitment strategy, and a low inclusion rate.
Conclusion:
The trial was terminated early due to slow recruitment and was therefore not powered to assess the effect of the prehabilitation intervention on postoperative complications. The findings suggest that the STRONG program seems promising for optimizing risky lifestyles, although these lifestyle results should be considered preliminary. Insights from this trial may help address recruitment challenges essential for completing a future adequately powered trial on postoperative complications.