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Preoperative Weight Loss for Open Abdominal Wall Reconstruction

RecruitingHealthy volunteers welcome

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Benjamin T. Miller · Participants: 258 · Started: Jun 19, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05925959

Locations in the U.S.

IllinoisNorthwestern University, Chicago
OhioCleveland Clinic Main Campus, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.