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Recruiting NCT05925959

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

No phase Interventional Abdominal Wall Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative Weight Management Program.
Who it may be relevant to
Registry conditions: Abdominal Wall Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Interventions

  • Other Preoperative 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-ob

Primary outcome measures

  • Abdominal core health-specific quality of life at 1 year [Time frame: 1 year]
Secondary outcome measures (12)
  • Hernia recurrence at 1 year [Time frame: 1 year]
  • Wound morbidity at 30 days [Time frame: 30 days]
  • Wound morbidity at 1 year [Time frame: 1 year]
  • Body composition changes in weight [Time frame: 1 year]
  • Body composition changes in BMI [Time frame: 1 year]
  • Patient abdominal wall specific- quality of life with preoperative weight management program [Time frame: 1 year]
  • Patient-reported pain changes with preoperative weight management program [Time frame: 1 year]
  • Patient-reported quality of life changes with preoperative weight management program [Time frame: 1 year]
  • Abdominal wall -specific quality of life short-term [Time frame: 30 days]
  • Pain scores [Time frame: 1 year]
  • Cost effective analysis [Time frame: 1 year]
  • Body weight percentage loss [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Northwestern University — Chicago
  • Cleveland Clinic Main Campus — Cleveland

Publications

  • 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 40434485

Identifiers

NCT: NCT05925959 · 23-418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗