What this trial means for you
This study is recruiting now at 2 US sites. It's studying see the official record for abdominal wall hernia.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
Illinois
- Northwestern University — Chicago · Recruiting now
Ohio
- Cleveland Clinic Main Campus — Cleveland · Recruiting now
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.
Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in
.env to activate this form.)