Obesity, Morbid Clinical Trial
Official title:
Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients
Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. The study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 15, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Nunzio Velotti | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Gagner M, Lacroix A, Bolte E. Laparoscopic adrenalectomy in Cushing's syndrome and pheochromocytoma. N Engl J Med. 1992 Oct 1;327(14):1033. doi: 10.1056/NEJM199210013271417. No abstract available. — View Citation
Leonetti F, Campanile FC, Coccia F, Capoccia D, Alessandroni L, Puzziello A, Coluzzi I, Silecchia G. Very low-carbohydrate ketogenic diet before bariatric surgery: prospective evaluation of a sequential diet. Obes Surg. 2015 Jan;25(1):64-71. doi: 10.1007/ — View Citation
Marescaux J, Mutter D, Wheeler MH. Laparoscopic right and left adrenalectomies. Surgical procedures. Surg Endosc. 1996 Sep;10(9):912-5. doi: 10.1007/BF00188482. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peri-operative complications | Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy | Complications occurring during surgery and within 30 days from surgery |
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