Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Benjamin T. Miller

Status

Enrolling

Conditions

Abdominal Wall Hernia

Treatments

Other: Preoperative Weight Management Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05925959

23-418

Details and patient eligibility

About

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.

Full 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.

Enrollment

258 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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