Preparing for hernia surgery: a trial too small to draw conclusions about complications

Targeted support before surgery

Conducted at two Danish university hospitals, the trial involved adults with at least one risk factor related to smoking, nutrition, alcohol or physical inactivity. Obesity was the most common factor. Around three in four participants had only one risk factor.

The researchers assigned participants to either usual care or the STRONG program. The program included six weekly hospital sessions combining education, motivational support and pharmaceutical support tailored to each patient's risk factors.

The primary outcome was the occurrence of complications within 30 days after surgery. Changes in lifestyle habits and quality of life were secondary outcomes. The final assessment of the primary outcome and the statistical analyses were blinded.

Changes in habits, without an established surgical benefit

At the end of the intervention, 13 of the 19 participants assessed in the STRONG group had optimized all their risk factors, compared with none of the 22 participants receiving usual care. However, the abstract does not specify the thresholds used to define this optimization. This finding remains preliminary.

After exclusions and accounting for surgeries that did not take place, complications were observed in 3 of the 16 people who underwent surgery in the STRONG group, compared with 4 of the 19 in the control group. These small numbers allow neither a reduction in complications to be established nor a conclusion that the two approaches are equivalent.

Quality-of-life findings were also mixed: the EQ-5D visual analog scale remained stable in the STRONG group and declined in the control group, while changes in the EQ-5D-5L index were similar between groups.

Recruitment limits what the trial can tell us

The initial calculation called for 199 participants per group. Only 43 people were randomized between March 2024 and May 2025. Slow recruitment led to the trial's early termination, leaving it without the statistical power needed to answer its primary question.

The authors report difficulties related in particular to outsourcing patient care, an inadequate recruitment strategy and a low enrollment rate. The study therefore mainly offers lessons for organizing a future trial, rather than evidence supporting the widespread use of this program before surgery.

What we can take away

STRONG provides a preliminary signal that lifestyle habits can be modified before ventral hernia surgery. It does not demonstrate that this support reduces postoperative complications.