Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial.
Daphne Remulla, Kimberly S Miles, Alvaro Carvalho...
https://pubmed.ncbi.nlm.nih.gov/40434485Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05925959
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Led by Benjamin T. Miller · Updated on 2026-03-23
258
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether preoperative intensive weight management is as effective as upfront surgery for obese patients undergoing complex abdominal wall reconstruction. This randomized controlled trial aims to compare abdominal wall-specific quality of life one year after surgery between patients who receive a 6-month medical weight loss program before surgery and those who proceed directly to surgery. The study focuses on adults with abdominal wall hernias and obesity, assessing quality of life using the HerQLes survey. The trial has two groups: one receives an intensive 6-month medical weight loss program led by obesity medicine specialists, including monthly visits with providers and dietitians, lifestyle changes, and possible anti-obesity medications tailored to the patient. The other group undergoes upfront open retromuscular ventral hernia repair without required preoperative weight loss. Surgery is performed by specialized hernia surgeons. Medication choices and diet plans are personalized based on health status and preferences. Participants will be involved in monthly visits during the weight management phase to monitor weight, vital signs, and adjust treatments. Researchers will assess quality of life related to abdominal core health at one year as the primary outcome, along with secondary outcomes such as hernia recurrence, wound complications, body composition changes, pain scores, and program adherence. Safety, cost effectiveness, and surgical outcomes will also be tracked. Total participation includes the preoperative period and one year of follow-up after surgery.
CONDITIONS
Brief Title
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults having open retromuscular ventral hernia repair with anticipated posterior component separation with transversus abdominis release and synthetic mesh
- Body mass index (BMI) between 40 and 55 kg/m2
- Not planning to pursue weight loss surgery due to ineligibility, insurance reasons, or personal choice
You will not qualify if you...
- 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 separate from definitive reconstruction
- BMI less than 40 or greater than 55 kg/m2
- Inability to participate in the Obesity Management Program due to insurance coverage or history of mental illness
- Presence of obstructive symptoms
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preoperative Weight Management Program
Duration - 6 months
Participants assigned to the weight management arm undergo a medical obesity intervention including monthly visits with an obesity medicine provider and dietitian focusing on lifestyle modifications and medication management tailored to individual needs.
5 follow-up monthly visits every 30 ± 7 days plus 1 initial visit (in-person or virtual)
Treatment
Duration - Duration of surgical procedure and immediate recovery
Participants undergo open retromuscular ventral hernia repair surgery with advanced abdominal wall reconstruction techniques.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year
Participants receive follow-up care to monitor wound morbidity, hernia recurrence, and quality of life outcomes up to 1 year after surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
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Research Team
B
Benjamin T Miller, MD
E
Erika Schmidt, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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