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

Recruiting

• Conditions: Obesity, Morbid; Adrenalectomy; Status
• Interventions: Dietary Supplement: Ketogenic diet

• Registration Number: NCT05816031
• Lead Sponsor: Federico II University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	Ketogenic diet	Patients scheduled to right laparoscopic adrenalectomy and belonging to the case arm, will be administered a standard 21 days ketogenic diet before surgery. 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.

Primary Outcome Measures

Name	Time	Method
Peri-operative complications	Complications occurring during surgery and within 30 days from surgery	Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy

Trial Locations

Locations (1)

Nunzio Velotti; 🇮🇹 Naples, Italy