Remulla Daphne, Miles Kimberly S, Carvalho Alvaro, Maskal Sara M, Butsch W Scott, Beffa Lucas R, Petro Clayton C, Krpata David M, Prabhu Ajita S, Rosen Michael J, Miller Benjamin T
Department of Surgery, Cleveland Clinic Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH, USA.
Department of Surgery, Bariatric and Metabolic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y.
Obesity is widely recognized as a risk factor for poor outcomes following ventral hernia repair. This belief has led many surgeons to implement arbitrary body mass index (BMI) cutoffs, typically 35-40 kg/m, before offering elective hernia repair. These practices are based on low-quality evidence and create significant challenges for patients with symptomatic hernias who lack access to metabolic and bariatric surgery or obesity medications. We aim to compare medical weight loss followed by surgery versus upfront surgery in patients with severe obesity undergoing ventral hernia repair.
This is a registry-based, parallel, randomized controlled trial with 1:1 allocation. A total of 258 patients with a BMI 40-55 kg/m who are planning to undergo open retromuscular ventral hernia repair are randomized to a six-month preoperative medical weight loss program followed by surgery or upfront surgery. The medical weight loss program is conducted by a nurse practitioner trained in obesity medicine. The primary hypothesis is that abdominal wall-specific quality of life, as measured by Hernia-Related Quality-of-Life Survey (HerQLes) summary scores at one year, for the upfront abdominal wall reconstruction intervention will be non-inferior compared to a preoperative medical weight loss program followed by surgery. Secondary outcomes include hernia recurrence rates at one-year, wound morbidity at 30 days and one year, and rates of emergency hernia repair, readmissions, complications, and reoperations between groups. Patient-reported outcomes include quality of life and pain scores at baseline, 30 days, and after completing the standard medical weight loss program. Weight-related outcomes include changes in weight from enrollment through one-year follow-up, rate of achievement of weight loss goals, and the association of weight loss and program completion on postoperative outcomes. Lastly, we will evaluate cost-effectiveness using quality-adjusted life years and incremental cost-effectiveness ratios.
Preoperative weight loss offers potential benefits for patients with obesity undergoing hernia repair including decreased wound morbidity, reduced technical difficulty, and potentially lower recurrence rates. However, disadvantages include prolonged diminished quality of life, risk of emergent hernia repair during the weight loss period, limited access to effective weight loss interventions, and challenges with adherence to weight loss protocols and long-term weight maintenance. This randomized controlled trial will provide high-quality evidence on whether intensive preoperative medical weight loss improves outcomes compared to immediate surgical repair in patients with severe obesity, helping to establish evidence-based guidelines for this challenging patient population.
NCT05925959 (registered June 22, 2023).
肥胖被广泛认为是腹疝修补术后预后不良的一个危险因素。这种观念导致许多外科医生在提供择期疝修补术前，实施任意的体重指数（BMI）临界值，通常为35至40kg/m²。这些做法基于低质量证据，给那些无法获得代谢和减重手术或肥胖症药物治疗的有症状疝患者带来了重大挑战。我们旨在比较在接受腹疝修补术的重度肥胖患者中，先进行医学减重再手术与直接手术的效果。
这是一项基于登记的、平行的随机对照试验，采用1:1分配。共有258名计划接受开放性肌后腹疝修补术、BMI为40至55kg/m²的患者被随机分为两组，一组接受为期六个月的术前医学减重计划，之后进行手术；另一组直接进行手术。医学减重计划由一名接受过肥胖医学培训的执业护士实施。主要假设是，与先进行术前医学减重计划再手术相比，直接进行腹壁重建干预在一年时通过疝相关生活质量调查（HerQLes）总结评分衡量的腹壁特定生活质量不会更差。次要结局包括一年时的疝复发率、30天和一年时的伤口发病率，以及两组之间的急诊疝修补率、再入院率、并发症发生率和再次手术率。患者报告的结局包括基线、30天以及完成标准医学减重计划后的生活质量和疼痛评分。与体重相关的结局包括从入组到一年随访期间的体重变化、减重目标达成率，以及体重减轻和计划完成与术后结局的关联。最后，我们将使用质量调整生命年和增量成本效益比来评估成本效益。
术前减重对接受疝修补术的肥胖患者具有潜在益处，包括降低伤口发病率、减少技术难度以及可能降低复发率。然而，缺点包括生活质量长期下降、减重期间急诊疝修补的风险、有效减重干预措施的可及性有限，以及遵守减重方案和长期维持体重方面的挑战。这项随机对照试验将提供高质量证据，以证明与立即手术修复相比，强化术前医学减重是否能改善重度肥胖患者的结局，有助于为这一具有挑战性的患者群体制定循证指南。
NCT05925959（2023年6月22日注册）
