NCT05816031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

April 2, 2023

Last Update Submit

September 21, 2023

Conditions

Adrenalectomy; StatusObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Peri-operative complications

    Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy

    Complications occurring during surgery and within 30 days from surgery

Study Arms (2)

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

No ketogenic diet

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

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

Ketogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy

Ketogenic diet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requiring laparoscopic right adrenalectomy

You may qualify if:

  • BMI \> 30 Kg/m2
  • Planned for laparoscopic right adrenalectomy
  • Age \> 18y.o.
  • No contraindications for ketogenic diet

You may not qualify if:

  • Diabetes
  • Patients requiring conversion to open surgery
  • BMI \< 30 Kg/m2
  • Age \< 18 y.o.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nunzio Velotti

Naples, 80131, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 8703150RESULT

  • 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.

    PMID: 1387700RESULT

  • 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/s11695-014-1348-1.

    PMID: 25005809RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Mario Musella

    Federico II University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Musella

CONTACT

00390817462880mario.musella@unina.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 18, 2023

Study Start

January 1, 2020

Primary Completion

October 30, 2023

Study Completion

December 15, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)