Adrenal TumorNCT06050057
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
An observational study of Adrenal Tumor and Adrenal Disease, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are: 1. to find the superiority of one the the surgical method mentioned above 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumor, Adrenal Disease, Adrenal Mass
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Sep 2023to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for adrenalectomy based on endocrinological and imaging examination. All patients older than 18 years who met the clinical criteria.
Who may be able to join
- Indicated adrenalectomy based on endocrinological and imaging examination.
- Written consent to participate in the study.
Who cannot join
- Simultaneous bilateral adrenalectomy.
- Adrenal expansion > 12 cm.
- Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University hospital Olomouc
Olomouc, 77900
Igor Hartmqnn, MD, PhD, +420588442895, igor.hartmann@fnol.cz
Natalia Wiesner, MD
About this study
Official title: Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:
- to find the superiority of one the the surgical method mentioned above
- to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.
- Conditions
- Adrenal Tumor, Adrenal Disease, Adrenal Mass, Adrenalectomy; Status, Adrenal Hyperplasia, Adrenal Gland Metastasis
- Keywords
- Adrenal Tumor, Pheochromocytoma, Conn Adenoma, Cushing Syndrome, Adrenalectomy, Laparoscopic surgery, da Vinci surgical system
- Medical subject headings
- Adrenal Gland Neoplasms, Adrenal Gland Diseases, Adrenal Hyperplasia, Congenital, Adrenal Cortex Diseases, Pheochromocytoma, Cushing Syndrome, Adrenocortical Adenoma, Adrenocortical Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial examination 1
Initial examination by a urologist and indication for the surgery.
Measured: 1 day
Initial examination 2
Sampling of biological material: Hemoglobin g/l
Measured: 1 day
Surgical period 1
Measuring the operation time in minutes.
Measured: 1 day
Surgical period 2
Measuring the blood loss in milliliters (ml).
Measured: 1 day
Surgical period 3
Record the need for conversion to open surgery.
Measured: 1 day
Surgical period 4
Record the surgical complications.
Measured: 1 day
Surgical period 5
The consumption of special surgical instruments.
Measured: 1 day
Perioperative period 1
Perioperatively, the length of stay in the ICU in days.
Measured: from 3- 7 days
Perioperative period 2
Perioperatively, total hospitalization time in days
Measured: from 3- 7 days
Perioperative period 3
Perioperatively, blood loss from the drain in mililiters (ml).
Measured: from 3- 7 days
Perioperative period 4
Perioperatively, time to remove the abdominal drain in days.
Measured: from 3- 7 days
Perioperative period 5
Perioperatively, need for blood substitutes.
Measured: from 3- 7 days
Perioperative period 6
Perioperatively, number of forced surgical revisions.
Measured: from 3- 7 days
Perioperative period 7
Perioperatively, consumption of analgesics during the hospitalization.
Measured: from 3- 7 days
First post-operative check-up 1
First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l
Measured: 1 day of examination, 14- 20 days from the surgery
First post-operative check-up 2
First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification
Measured: 1 day of examination, 14- 20 days from the surgery
First post-operative check-up 3
First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.
Measured: 1 day of examination, 14- 20 days from the surgery
Second post-operative check-up 1
Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.
Measured: 1 day of examination, 85-100 days from the surgery
Second post-operative check-up 2
Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions
Measured: 1 day of examination, 85-100 days from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start3 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, General University Hospital, Prague, University Hospital Hradec Kralove
- Responsible party
- Principal investigator, Natalia Wiesner, University Hospital Olomouc
- Investigators
- MUDr. Igor Hartmann Ph.D., Study chair, Dpt. of Urology, University hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050057
- Sponsor's protocol ID
- FNOL 122/23
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study
- ClinicalTrials.gov ID
- NCT06050057
- Acronym / sponsor ID
- FNOL 122/23
- Conditions
- Adrenal Tumor, Adrenal Disease, Adrenal Mass, Adrenalectomy; Status, Adrenal Hyperplasia, Adrenal Gland Metastasis
- Keywords
- Adrenal Tumor, Pheochromocytoma, Conn Adenoma, Cushing Syndrome, Adrenalectomy, Laparoscopic surgery, da Vinci surgical system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, General University Hospital, Prague, University Hospital Hradec Kralove
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Sep 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.
The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:
- to find the superiority of one the the surgical method mentioned above
- to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for adrenalectomy based on endocrinological and imaging examination. All patients older than 18 years who met the clinical criteria.
Key inclusion criteria (2 listed)
- Indicated adrenalectomy based on endocrinological and imaging examination.
- Written consent to participate in the study.
Key exclusion criteria (3 listed)
- Simultaneous bilateral adrenalectomy.
- Adrenal expansion > 12 cm.
- Suspected malignant adrenal tumor with infiltrative growth or tumor venous thrombus according to imaging examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Initial examination 1
Time frame: 1 day
Initial examination by a urologist and indication for the surgery.
Initial examination 2
Time frame: 1 day
Sampling of biological material: Hemoglobin g/l
Surgical period 1
Time frame: 1 day
Measuring the operation time in minutes.
Surgical period 2
Time frame: 1 day
Measuring the blood loss in milliliters (ml).
Surgical period 3
Time frame: 1 day
Record the need for conversion to open surgery.
Surgical period 4
Time frame: 1 day
Record the surgical complications.
Surgical period 5
Time frame: 1 day
The consumption of special surgical instruments.
Perioperative period 1
Time frame: from 3- 7 days
Perioperatively, the length of stay in the ICU in days.
Perioperative period 2
Time frame: from 3- 7 days
Perioperatively, total hospitalization time in days
Perioperative period 3
Time frame: from 3- 7 days
Perioperatively, blood loss from the drain in mililiters (ml).
Perioperative period 4
Time frame: from 3- 7 days
Perioperatively, time to remove the abdominal drain in days.
Perioperative period 5
Time frame: from 3- 7 days
Perioperatively, need for blood substitutes.
Perioperative period 6
Time frame: from 3- 7 days
Perioperatively, number of forced surgical revisions.
Perioperative period 7
Time frame: from 3- 7 days
Perioperatively, consumption of analgesics during the hospitalization.
First post-operative check-up 1
Time frame: 1 day of examination, 14- 20 days from the surgery
First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l
First post-operative check-up 2
Time frame: 1 day of examination, 14- 20 days from the surgery
First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification
First post-operative check-up 3
Time frame: 1 day of examination, 14- 20 days from the surgery
First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.
Second post-operative check-up 1
Time frame: 1 day of examination, 85-100 days from the surgery
Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.
Second post-operative check-up 2
Time frame: 1 day of examination, 85-100 days from the surgery
Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions
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.
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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.
MUDr. Igor Hartmann Ph.D. study chair
Dpt. of Urology, University hospital Olomouc
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 Adrenal Tumor and Adrenal Disease, run by University Hospital Olomouc at 1 site in Czechia.
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 2 inclusion and 3 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 Czechia. 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 MUDr. Igor Hartmann Ph.D. (+420588442895, Igor.Hartmann@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial examination 1 (time frame: 1 day). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.