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RECRUITING
NCT05925959
NA

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Sponsor: Benjamin T. Miller

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

258

Start Date

2023-06-19

Completion Date

2027-06-01

Last Updated

2026-03-23

Healthy Volunteers

Yes

Interventions

OTHER

Preoperative Weight Management Program

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.

Locations (2)

Northwestern University

Chicago, Illinois, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States