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

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05816031

Collaborator

(none)

Enrollment

Location

42.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adrenalectomy; Status Obesity, Morbid	Dietary Supplement: 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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Ketogenic diet Ketogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy
No ketogenic diet Ketogenic diet will not be prescribed to patients belonging to control group.

Arm

Intervention/Treatment

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.

Dietary Supplement: Ketogenic diet

Ketogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy

No ketogenic diet

Ketogenic diet will not be prescribed to patients belonging to control group.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nunzio Velotti	Naples		Italy	80131

Sponsors and Collaborators

Federico II University

Investigators

Principal Investigator: Mario Musella, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mario Musella MD, Professor, Federico II University

ClinicalTrials.gov Identifier:

NCT05816031

Other Study ID Numbers:

KetoAdreno

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Apr 18, 2023