Preoperative Weight Loss for Open Abdominal Wall Reconstruction
1 other identifier
interventional
258
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedStudy Start
First participant enrolled
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 23, 2026
October 1, 2025
4 years
June 14, 2023
March 19, 2026
Conditions
Outcome Measures
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.
1 year
Secondary Outcomes (20)
Hernia recurrence at 1 year
1 year
Wound morbidity at 30 days
30 days
Wound morbidity at 1 year
1 year
Body composition changes in weight
1 year
Body composition changes in BMI
1 year
- +15 more secondary outcomes
Study Arms (2)
Upfront Surgery
NO INTERVENTIONPreoperative Weight Management Program
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University
Chicago, Illinois, 60611, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
Related Publications (1)
Remulla D, Miles KS, Carvalho A, Maskal SM, Butsch WS, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Rosen MJ, Miller BT. Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial. Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y.
PMID: 40434485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin T Miller, MD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessor of the patient reported outcomes will be blinded. Hernia recurrence will be assessed by blinded review of CT scans by 3 surgeons.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 14, 2023
First Posted
June 29, 2023
Study Start
June 19, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 23, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share