Weight loss before surgery for abdominal wall hernia repair
Official title: Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Run by The Cleveland Clinic · NCT05925959 · Data updated 2026-11-12
This study is testing if a weight loss program before surgery can help people with obesity have better results after abdominal wall hernia repair compared to those who have surgery right away.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 258 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | June 19, 2023 |
| Main results expected | June 1, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT05925959 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a BMI between 40-55 kg/m2 who require open retromuscular ventral hernia repair and are not pursuing weight loss surgery.
✕Probably not a fit
Patients who are not fluent in English, have urgent repair needs, or have a BMI outside the specified range will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to compare the effects of a preoperative intensive weight management program against immediate surgery for obese patients undergoing complex abdominal wall reconstruction. Participants will be randomly assigned to either a 6-month medical weight loss program or to receive surgery without prior weight loss. The study will assess the quality of life specific to abdominal wall conditions using the HerQLes survey to determine if the surgical outcomes are comparable between the two groups. Conducted at Cleveland Clinic, the program will involve a team of specialists in weight loss medicine.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for obese patients undergoing abdominal wall reconstruction.
How similar studies have gone: Other studies have shown promising results with preoperative weight management in surgical outcomes, suggesting this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Northwestern University
Chicago, Illinois, United States Recruiting -
Cleveland Clinic Main Campus
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Benjamin T Miller, MD — The Cleveland Clinic
- Study coordinator: Benjamin T Miller, MD
- Email: millerb35@ccf.org
- Phone: 216 406-8573
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing suture mesh and planar mesh for small ventral hernia repair
This trial will test whether using mesh-suture instead of planar mesh during repair of small ventral hernias in adults leads to fewer wound problems, better quality of life, and shorter operation times.
-
International registry for emergency surgery and trauma
This study is setting up a worldwide registry for emergency surgeries and trauma cases to help doctors track their results and find better ways to treat patients.
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Transplanting abdominal wall tissue to repair defects
This study is testing if transplanting abdominal wall tissue can safely fix defects in the abdominal area for people who need it.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.