Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Contact Information
Primary
Benjamin T Miller, MD
millerb35@ccf.org
216 406-8573
Backup
Daphne Remulla, MD
REMULLD@ccf.org
216 399-7047
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 258
Treatments
No_intervention: Upfront Surgery
Active_comparator: Preoperative Weight Management Program
Related Therapeutic Areas
Sponsors
Leads: Benjamin T. Miller

This content was sourced from clinicaltrials.gov