Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients

Obesity, Morbid Clinical Trial

Official title:

Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816031
• Other study ID #: KetoAdreno
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adrenalectomy; Status
• Obesity, Morbid

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