Recruiting

Weight Loss

Sponsor:

Benjamin T. Miller

Code:

NCT05925959

Conditions

Abdominal Wall Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Preoperative Weight Management Program

Study Details

Brief 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.

Conditions

Abdominal Wall Hernia

Study ID

NCT05925959

Start date

Jun 19, 2023

Status verified date

Oct, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Upfront Surgery

active comparator: Preoperative Weight Management Program

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Benjamin T Miller, MD

216 406-8573millerb35@ccf.org

Erika Schmidt, MD

2163723107schmide7@ccf.org

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Megan Melland-Smith, MD

312-907-1414megan.mellandsmith@nm.org

Nancy Ly, MD

262-455-1560nancy.ly@nm.org

Principal Investigator:

Megan Melland-Smith, MD

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Benjamin T Miller, MD

2164068573millerb35@ccf.org

More Information

Sponsor

Benjamin T. Miller

Last update posted

Mar 23, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Benjamin T. Miller on 2026-03-23.