Effects of a Ketogenic Diet on Surgery Outcomes for Obese Patients
Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients
This study is testing if following a ketogenic diet for three weeks before surgery can help obese patients have safer and easier laparoscopic adrenal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05816031 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a ketogenic diet on intra- and peri-operative complications in morbidly obese patients undergoing right laparoscopic adrenalectomy. Patients with a body mass index over 30 Kg/m2 will be divided into two groups: one receiving a ketogenic diet for 21 days prior to surgery and the other not receiving the diet. The aim is to determine if the ketogenic diet can reduce liver size, thereby facilitating a safer and more efficient surgical procedure. Both groups will undergo abdominal ultrasound before the surgery to assess liver size.
Who should consider this trial
Good fit: Ideal candidates are morbidly obese patients with a BMI over 30 scheduled for laparoscopic right adrenalectomy.
Not a fit: Patients with diabetes or those requiring conversion to open surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for obese patients undergoing adrenalectomy.
How similar studies have performed: While ketogenic diets have been explored in bariatric surgery, this specific application in adrenalectomy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \> 30 Kg/m2 * Planned for laparoscopic right adrenalectomy * Age \> 18y.o. * No contraindications for ketogenic diet Exclusion Criteria: * Diabetes * Patients requiring conversion to open surgery * BMI \< 30 Kg/m2 * Age \< 18 y.o.
Where this trial is running
Naples
- Nunzio Velotti — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Mario Musella — Federico II University
- Study coordinator: Mario Musella
- Email: mario.musella@unina.it
- Phone: 00390817462880
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.