Preoperative Weight Loss for Open Abdominal Wall Reconstruction
ConditionAbdominal Wall Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin T. Miller
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Lack of English language fluency
Urgent need for repair as determined by surgeon judgement
Pregnant patients
Permanent stoma in place
Trial design
Treatments tested in this trial
- Preoperative Weight Management Program
Treatment groups
258 Participants
are divided into 2 treatment groupsSponsors and collaborators
Benjamin T. Miller
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov