|

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

RECRUITINGN/ASponsored by Benjamin T. Miller
Actively Recruiting
PhaseN/A
SponsorBenjamin T. Miller
Started2023-06-19
Est. completion2027-06-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Abdominal Wall HerniaWeight Loss

Locations1 site

Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Benjamin T Miller, MD2164068573millerb35@ccf.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.