RecruitingNot ApplicableNCT05925959

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Sponsor

Benjamin T. Miller

Enrollment

258 participants

Start Date

Jun 19, 2023

Study Type

INTERVENTIONAL

Conditions

Abdominal wall hernia

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria9

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

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Interventions

OTHERPreoperative Weight Management Program

The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days.