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

F

Federico II University

Status

Enrolling

Conditions

Adrenalectomy; Status
Obesity, Morbid

Treatments

Dietary Supplement: Ketogenic diet

Study type

Observational

Funder types

Other

Identifiers

NCT05816031
KetoAdreno

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Ketogenic diet
Description:
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.
Treatment:
Dietary Supplement: Ketogenic diet
No ketogenic diet
Description:
Ketogenic diet will not be prescribed to patients belonging to control group.

Trial contacts and locations

1

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Central trial contact

Mario Musella

Data sourced from clinicaltrials.gov

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