Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Обзор

The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.

Подробное описание

This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Вмешательства

• Другое Preoperative Weight Management Program
  The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-ob

Первичные конечные точки

• Abdominal core health-specific quality of life at 1 year [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Hernia recurrence at 1 year [Срок оценки: 1 year]
• Wound morbidity at 30 days [Срок оценки: 30 days]
• Wound morbidity at 1 year [Срок оценки: 1 year]
• Body composition changes in weight [Срок оценки: 1 year]
• Body composition changes in BMI [Срок оценки: 1 year]
• Patient abdominal wall specific- quality of life with preoperative weight management program [Срок оценки: 1 year]
• Patient-reported pain changes with preoperative weight management program [Срок оценки: 1 year]
• Patient-reported quality of life changes with preoperative weight management program [Срок оценки: 1 year]
• Abdominal wall -specific quality of life short-term [Срок оценки: 30 days]
• Pain scores [Срок оценки: 1 year]
• Cost effective analysis [Срок оценки: 1 year]
• Body weight percentage loss [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
• BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.

Критерии исключения

• Lack of English language fluency
• Urgent need for repair as determined by surgeon judgement
• Pregnant patients
• Permanent stoma in place
• Isolated flank hernia
• Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
• BMI <40 or >55 kg/m2
• Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
• Obstructive symptoms

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Northwestern University — Chicago
• Cleveland Clinic Main Campus — Cleveland

Публикации

• Remulla D, Miles KS, Carvalho A, Maskal SM, Butsch WS, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Rosen MJ, Miller BT. Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial. Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y. PMID 40434485

Идентификаторы

NCT: NCT05925959 · 23-418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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