Preoperative Weight Loss for Open Abdominal Wall Reconstruction

NCT05925959 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether losing weight before surgery helps improve quality of life for people with abdominal wall hernias who are planning to have open abdominal wall reconstruction.

Status Recruiting Currently enrolling participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 258 people Planned (estimated).

Who can join Ages 18+ · all sexes Healthy volunteers accepted.

Timeline Started 2023-06 · est. completion 2027-06

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT05925959 ↗

Description as written by the study sponsor.

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.

Treatments tested

Preoperative Weight Management Program Other

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-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days.

Main thing measured	Abdominal core health-specific quality of life at 1 year
Sponsor	Benjamin T. Miller
Conditions studied	Abdominal Wall Hernia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05925959 ↗