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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05816031
Other study ID # KetoAdreno
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 15, 2023

Study information

Verified date September 2023
Source Federico II University
Contact Mario Musella
Phone 00390817462880
Email mario.musella@unina.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. Due to a standard trans abdominal laparoscopic right adrenalectomy is performed with the patient in left lateral position, it is necessary to retract liver in order to expose the right adrenal gland and the cava vein. It is therefore evident how a reduced size liver may allow a faster, easier and safer surgery. Finding a normal size liver is uncommon in patients presenting with a body mass index above 30 Kg/m2. According to this, patients scheduled to right laparoscopic adrenalectomy and belonging to the case arm, will be administered a standard 21 days ketogenic diet before surgery. Conversely this will not be prescribed to patients belonging to control group. Ketogenic diet is based on a standard diet plus a ketogenic product to be taken once daily for 21 days. In both groups patients will undergo abdominal ultrasound before surgery.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ketogenic diet
Ketogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy

Locations

Country Name City State
Italy Nunzio Velotti Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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

Outcome

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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