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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05925959
Study type Interventional
Source The Cleveland Clinic
Contact Benjamin T Miller, MD
Phone 216 406-8573
Email millerb35@ccf.org
Status Recruiting
Phase N/A
Start date June 19, 2023
Completion date June 1, 2027

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