CHICAGO – Elective ventral hernia repair improves hernia-related quality of life for low- to moderate-risk patients, according to findings from a prospective patient-centered study.

The findings suggest that the risks and benefits of a conservative operative strategy should be reassessed, and that patient-centered outcomes should be considered, Dr. Julie Holihan reported at the annual meeting of the American Surgical Association.

Of 152 patients with a ventral hernia from a single hernia clinic, 97 were managed non-operatively, and 55 were managed operatively. In a propensity-matched cohort of 90 patients with similar demographics, baseline comorbidities, and quality of life scores, only operatively managed patients had improved quality of life scores at 6 months (improvement from 34.7 to 56.9 vs. from 35.6 to 36.6), according to Dr. Holihan of the University of Texas, Houston.

Further, satisfaction scores increased significantly more in the operative than in the non-operative group at follow-up (from a median score of 2 at baseline in both groups to scores of 9 and 3, respectively), and pain scores decreased significantly more in the operative group than in the non-operative group (from a baseline score of 5 down to 3 in the operative group, with no change [score of 6] in the non-operative group).

Two surgical site infections and one hernia recurrence occurred in the operative group.

Notably, the predicted risk of surgery in the cohort was much greater than the observed risk.

“We may be overestimating surgical risk in these patients,” she said.

Based on a multivariable analysis in the overall cohort, non-operative management was strongly associated with lower quality of life score (coefficient, -26.5), Dr. Holihan said.

Nonoperative management of ventral hernias is often recommended for patients, particularly in those with increased risk of surgical complications due to factors such as obesity, poorly controlled diabetes, smoking, or significant comorbidities like coronary artery disease, but this approach to management has not been well studied with respect to patient-centered outcomes such as quality of life and function, she explained.

Traditional outcomes that have been studied, including infection and hernia recurrence, may not be the outcomes that are most important to patients, she added.

For the current study, patients with ventral hernias were prospectively enrolled between June 2014 and June 2015. Non-operative management was recommended for smokers, those with a body mass index greater than 33 kg/m², and those with poorly controlled diabetes. Measured outcomes included surgical site infection, hernia recurrence, and quality of life using a validated quality of life measure.

This is the first prospective study comparing management strategies in ventral hernia patients with comorbidities, Dr. Holihan said.

She concluded that “the elective repair of ventral hernia, compared with non-operative management, improves patient-centered outcomes in similar-risk patients.”

“Furthermore, the low occurrence of complications suggests that we may be overestimating surgical risk and that we may be too conservative in our patient selection for elective ventral hernia repair. It may be time to reevaluate patient selection criteria in order to better incorporate patient-centered outcomes,” she said.

In response to a question about managing patients with higher risk and/or higher BMI, Dr. Holihan’s coauthor, Dr. Mike K. Liang, also of the University of Texas, Houston, noted that the findings of the study provide estimates for potential future randomized trials. He also noted that the moderate-risk patients at the center often undergo “prehabilitation,” or a preoperative exercise and diet program designed to help optimize outcomes. Currently, patients with BMI of 30-40 kg/m² are randomized to preoperative rehabilitation vs. current care.

“BMI is a very important decision making factor. We were not able to pick a standardized point [with respect to BMI] for when to operate vs. non-operate. Because of that, we used BMI as a factor in developing our propensity score,” he said, explaining that this is why the propensity-matched groups had similar BMI, while the non-operative group in the overall cohort had substantially higher BMI.

A randomized trial on prehabilitation may be able to provide some insight into the effects of rapid changes in weight and how they affect outcomes in order to make the best choices regarding surgery.

“We do hypothesize that significant weight loss prior to surgery may improve outcomes, and may make the abdominal wall more compliant and enable us to tackle more challenging hernias. We also hypothesize that patients who have a sudden increase in weight after having their ventral hernia repaired may end up having worse outcomes. Hopefully in the next year we will be able to shed more light on these very important questions.”

The authors reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

Consider patient-centered outcomes in ventral hernia repair decision