Adrenalectomy; StatusNCT05816031
Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients
An observational study of Adrenalectomy; Status and Obesity, Morbid, run by Federico II University at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adrenalectomy; Status, Obesity, Morbid
- What is being tested?
- Ketogenic diet
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring laparoscopic right adrenalectomy
Who may be able to join
- BMI > 30 Kg/m2
- Planned for laparoscopic right adrenalectomy
- Age > 18y.o.
- No contraindications for ketogenic diet
Who cannot join
- Diabetes
- Patients requiring conversion to open surgery
- BMI < 30 Kg/m2
- Age < 18 y.o.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Nunzio Velotti
Naples, 80131
Nunzio Velotti, +3921417424, nunzio.velotti@gmail.com
About this study
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.
Read the 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.
- Conditions
- Adrenalectomy; Status, Obesity, Morbid
- Being tested
- Ketogenic diet
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
Ketogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ketogenic diet | |
| No ketogenic diet | Ketogenic diet will not be prescribed to patients belonging to control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative complications
Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy
Measured: Complications occurring during surgery and within 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jan 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adrenalectomy; StatusStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Musella MD, Federico II University
- Investigators
- Mario Musella, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816031
- Sponsor's protocol ID
- KetoAdreno
- Status last verified
- Sep 2023
- First submitted
- 2 Apr 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8703150Gagner 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.
PubMed 1387700Leonetti 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.
PubMed 25005809
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients
- ClinicalTrials.gov ID
- NCT05816031
- Acronym / sponsor ID
- KetoAdreno
- Conditions
- Adrenalectomy; Status, Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | – | Dietary Supplement: Ketogenic dietPatients 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. |
| No ketogenic diet | – | –Ketogenic diet will not be prescribed to patients belonging to control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring laparoscopic right adrenalectomy
Key inclusion criteria (4 listed)
- BMI > 30 Kg/m2
- Planned for laparoscopic right adrenalectomy
- Age > 18y.o.
- No contraindications for ketogenic diet
Key exclusion criteria (4 listed)
- Diabetes
- Patients requiring conversion to open surgery
- BMI < 30 Kg/m2
- Age < 18 y.o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietKetogenic diet administrated to obese patients planned for right laparoscopic adrenalectomy | Dietary supplement | Ketogenic diet |
Primary outcome
Peri-operative complications
Time frame: Complications occurring during surgery and within 30 days from surgery
Pre and post-operative (within 30 days) complications of laparoscopic adrenalectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Results publication: PubMed 8703150Marescaux J, Mutter D, Wheeler MH. Laparoscopic right and left adrenalectomies. Surgical procedures. Surg Endosc. 1996 Sep;10(9):912-5. doi: 10.1007/BF00188482.
- Results publication: PubMed 1387700Gagner 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.
- Results publication: PubMed 25005809Leonetti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Musella principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenalectomy; Status and Obesity, Morbid, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Musella (00390817462880, mario.musella@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative complications (time frame: Complications occurring during surgery and within 30 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816031, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.