Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Recruiting now · Not applicable
Conditions studied: Abdominal Wall Hernia
In brief
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 facts
- Study ID
- NCT05925959
- Run by
- Benjamin T. Miller
- People needed
- 258
- Starts
- 2023-06-19
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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