Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Benjamin T. Miller
Study ID
NCT05925959
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Wall Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Jun 19, 2023
Status verified
Oct 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Upfront Surgery
  • Active Comparator: Preoperative Weight Management Program

Primary Outcome Measure

Abdominal core health-specific quality of life at 1 year [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Megan Melland-Smith, MD
[email protected]
312-907-1414
Nancy Ly, MD
[email protected]
262-455-1560
Megan Melland-Smith, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Main CampusClevelandOhio44195
Benjamin T Miller, MD
[email protected]
2164068573

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By research site
Northwestern University· Chicago, ILCleveland Clinic Main Campus· Cleveland, OH

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