Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial

Area of Science:

• Surgical Oncology
• Bariatric Surgery
• Clinical Trials

Background:

• Obesity is a known risk factor for poor outcomes in ventral hernia repair.
• Current practices often use arbitrary BMI cutoffs (35-40 kg/m²), limiting access to care.
• This study addresses the need for evidence-based guidelines for severe obesity (BMI 40-55 kg/m²).

Purpose of the Study:

• To compare outcomes of upfront surgery versus preoperative medical weight loss in patients with severe obesity undergoing ventral hernia repair.
• To evaluate the non-inferiority of upfront surgery compared to preoperative weight loss regarding abdominal wall quality of life.
• To assess secondary outcomes including hernia recurrence, wound morbidity, and patient-reported outcomes.

Main Methods:

• A registry-based, parallel, randomized controlled trial with 1:1 allocation.
• 258 patients with BMI 40-55 kg/m² randomized to either a 6-month preoperative medical weight loss program or upfront open retromuscular ventral hernia repair.
• Primary outcome: Hernia-Related Quality-of-Life Survey (HerQLes) summary scores at one year.

Main Results:

• Primary hypothesis: Upfront surgery will be non-inferior to preoperative weight loss in improving one-year HerQLes scores.
• Secondary outcomes: Hernia recurrence, wound morbidity, emergency repairs, readmissions, complications, and reoperations.
• Patient-reported outcomes and weight-related changes will be analyzed.

Conclusions:

• Preoperative weight loss may reduce wound morbidity and technical difficulty but poses risks like prolonged diminished quality of life and emergent repairs.
• This trial will provide high-quality evidence to guide clinical practice for hernia repair in severely obese patients.
• Findings will help establish evidence-based guidelines for managing this patient population.