NCT05925959NARecruitingAccepts Healthy Volunteers

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Benjamin T. Miller

Start Date

6/19/2023

Completion Date

6/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria * 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. Exclusion criteria * 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

Interventions

OTHER

Preoperative Weight Management Program

Interested in This Trial?

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Conditions

Abdominal Wall Hernia

Locations

Northwestern University

Chicago, Illinois 60611

United States

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States