Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Benjamin T. Miller · NCT05925959
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 258
- US sites recruiting
- 2
- Study start
- June 19, 2023
- Record last updated
- March 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is 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.
Being studied: Preoperative Weight Management Program
Conditions: Abdominal Wall Hernia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Northwestern University
Chicago, IL 60611
Site contact: Megan Melland-Smith, MD · 312-907-1414 · megan.mellandsmith@nm.org
Cleveland Clinic Main Campus
Cleveland, OH 44195
Site contact: Benjamin T Miller, MD · 2164068573 · millerb35@ccf.org
Study contacts (from the official record)
- Benjamin T Miller, MD · 216 406-8573 · millerb35@ccf.org
- Erika Schmidt, MD · 2163723107 · schmide7@ccf.org
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