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/40434485/Actively Recruiting
Led by Benjamin T. Miller · Updated on 2026-03-23
258
Participants Needed
2
Research Sites
N/A
Total Duration
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
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
B
Benjamin T Miller, MD
E
Erika Schmidt, MD
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Benjamin T. Miller
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Weight‑loss program before surgery | Immediate hernia repair | Usual care without structured weight‑loss requirement |
|---|---|---|---|
| What it is | Structured medical weight management program before surgery | Immediate open ventral hernia repair without preoperative weight-loss requirement | Typical clinical practice often encourages preoperative weight loss but lacks a standardized structured program |
| Role in trial | Investigational intervention arm undergoing structured weight-loss prior to repair | Control arm receiving hernia repair without preoperative program | Represents typical clinical approach where preoperative weight loss may be advised but not protocolized |
| Primary use | Optimize weight and health before surgery | Proceed directly to hernia repair without required preoperative preparation | Allow surgery without structured weight program, with optional general advice |
| How it is given or performed | Monthly visits with obesity medicine provider ± dietitian, lifestyle support plus anti‑obesity medication options over ~6 months | Standard surgical scheduling without structured preoperative program | Advice varies by clinician; no fixed schedule or pharmacologic prehabilitation is routine |
| Evidence status | Efficacy under investigation; no results available yet | Efficacy under investigation as control in this trial | Limited randomized evidence supports pre‑op weight loss efficacy; one RCT showed short‑term benefit, overall evidence is low quality |
| Important limitations | Effect on long‑term surgical outcomes not yet known | Does not test whether structured pre‑op optimization could reduce complications | Evidence is sparse and mostly non‑standardized; RCT data are few and with low certainty |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Daphne Remulla, Kimberly S Miles, Alvaro Carvalho...
https://pubmed.ncbi.nlm.nih.gov/40434485/Benjamin T. Miller
Lead Sponsor