Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Preoperative Weight Management Program

    Other intervention

    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.

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: Upfront SurgeryNo intervention 0 interventions
Group B: Preoperative Weight Management ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Abdominal core health-specific quality of life at 1 year

This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life.

Time frame
1 year

Secondary outcomes

1

Hernia recurrence at 1 year

This will be based on based on the current consensus definition of hernia recurrence which considers CT scan reviewed by 3 blinded assessors, surgeon clinical exam, and patient-reported bulge.

Time frame
1 year
2

Wound morbidity at 30 days

This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.

Time frame
30 days
3

Wound morbidity at 1 year

This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.

Time frame
1 year
4

Body composition changes in weight

This includes comparative mean changes in body weight (kg) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benjamin T. Miller

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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