Preoperative Weight Loss for Open Abdominal Wall Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Abdominal core health-specific quality of life at 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor of the patient reported outcomes will be blinded. Hernia recurrence will be assessed by blinded review of CT scans by 3 surgeons.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Abdominal core health-specific quality of life at 1 year
时间窗: 1 year
This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life.
次要结局
- Hernia recurrence at 1 year(1 year)
- Patient abdominal wall specific- quality of life with preoperative weight management program(1 year)
- Pain scores(1 year)
- Body weight percentage loss(1 year)
- Weight management program adherence(1 year)
- Wound morbidity at 30 days(30 days)
- Wound morbidity at 1 year(1 year)
- Urgent repair(1 year)
- Impact of 10% body weight loss on wound complications(1 year)
- Impact of 10% body weight loss on hernia recurrence(1 year)
- Bariatric surgery prior to hernia repair and wounds(1 year)
- Bariatric surgery prior to hernia repair and hernia recurrence(1 year)
- Bariatric surgery prior to hernia repair and abdominal wall specific quality of life(1 year)
- Body composition changes in weight(1 year)
- Body composition changes in BMI(1 year)
- Patient-reported pain changes with preoperative weight management program(1 year)
- Patient-reported quality of life changes with preoperative weight management program(1 year)
- Cost effective analysis(1 year)
- Abdominal wall -specific quality of life short-term(30 days)
- Impact of 10% body weight loss(1 year)
研究者
Benjamin T. Miller
Assistant Professor
The Cleveland Clinic