Weight loss before surgery for abdominal wall hernia repair
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05925959 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with preoperative weight management in surgical outcomes, suggesting this approach may be beneficial.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.