AdrenalectomyROBADRENCT07110168
Robot-assisted Adrenalectomy, Feasibility and Results
An observational study of Adrenalectomy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To date, laparoscopy is considered to be the gold standard technique for adrenalectomy. Robotic surgery is beginning to be used, but no series of more than 300 procedures has yet allowed the morbidity, benefits and learning curve of this technique to be assessed. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adrenalectomy
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent robot-assisted adrenalectomy in Department of Visceral Metabolic and Oncologic surgery Department
Who may be able to join
- all patient who underwent unilateral robot-assisted adrenalectomy
Who cannot join
- bilateral adrenalectomy
- adrenalectomy by laparotomy
- partial adrenalectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot-assisted Adrenalectomy, a Retrospective Single-center Study of 700 Procedures.
To date, laparoscopy is considered to be the gold standard technique for adrenalectomy. Robotic surgery is beginning to be used, but no series of more than 300 procedures has yet allowed the morbidity, benefits and learning curve of this technique to be assessed. Furthermore, the debate on the benefits of using robotic tools when performing adrenalectomies remains open. At Nancy University Hospital, we have been performing robotic procedures on 90% of our patients since 2009, and have seen a significant increase in patient numbers (currently between 80 and 90 per year).
In 2019, we published a series of 300 patients, describing the results of the technique.
Read more
Based on our clinical experience and the growing interest of the surgical community, we believe that describing our cohort of patients who have undergone robot-assisted surgery (estimated at 600 patients) is of unquestionable scientific interest.
In 2018, the American team at UCLA published a series of 640 laparoscopic adrenalectomies and examined the risk factors for complications following this surgery. Given the team's reputation and their publication in the leading surgical journal (JAMA Surgery), we used the same criteria for our data collection to make our results comparable.
This study aims to evaluate the risk factors for surgical complications after robotic adrenalectomy in a large retrospective series. Our aim is to demonstrate the safety and reliability of this technique and to identify patients at greatest risk of complications. This may encourage the adoption of the technique in other centres.
Read the detailed description
Main objective:Evaluation of postoperative morbidity (Clavien-Dindo >2) 30 days after robot-assisted unilateral adrenalectomy
Secondary objective(s):
- Identify risk factors associated with the occurrence of complications after surgery. (patients characteristics, adrenal disease type)
- Determine the learning curve of robotic adrenalectomy considering surgical morbidity (Clavien Dindo>2)
- Determine the learning curve of robotic adrenalectomy considering operative time
Data collection:
PREOPERATIVE
Adrenal disease :
- Conn's adenoma
- Pheochromocytoma
- Cushing's adenoma
- Non-secreting adenoma
- Metastases (specify primary site: kidney, lung, skin)
- Virilising tumour
- Adrenal cancer (adrenocortical carcinoma)
- Haematological disorders
- Other
Patient characteristics:
- Age
- BMI
- ASA score
- Sex
- Comorbidity (Charleston score?)
- History of abdominal surgery/specify the procedure, noting whether it was laparoscopic or laparotomy
- History of adrenal surgery
- Genetic disease: NEM, VHL, etc.
Intra-operative data :
- Preoperative blood pressure
- Tumour laterality
- Surgeon
- Operative time
- Perioperative complications: bleeding, digestive tract injury, etc. ( using the KAARAFANI classification)
- Conversion to laparotomy and cause: adhesions, bleeding, digestive tract injury
Post-operative data :
- Length of hospital stay in days
- Morbidity: complications within 30 days after surgery according to Clavien-Dindo
- Mortality
- Conditions
- Adrenalectomy
- Keywords
- adrenalectomy, robotic surgery, robot-assisted surgery, transperitoneal adrenalectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent robot assisted adrenalectomy in University Hospital of Nancy | All patients who underwent a robotic adrenalectomy (all adrenal disease included) in the Department of Visceral,Metabolic and Oncologic surgery in University Hospital of Nancy between 01.01.2013 and 12.31.2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity after robotic adrenalectomy
evaluation of morbidity after robotic adrenalectomy in the 30 days after surgery using Clavien Dindo classification
Measured: from enrollment to 30 days after surgery
Secondary outcomes (3)
factors associated with clavien Dindo morbidity>2
Using the data base, identification of factors related to patient or to adrenal disease associated with a higher post-operative morbidity
Measured: from enrollment to 30 days after surgery
Learning curve
To determinate the learning curve of robotic adrenalectomy with a significant decrease of post-operative morbidity (number of cases)
Measured: from enrollment to 30 days after surgery
Learning curve - operative time
To determinate the number of procedure necessary to significantly decrease the operative time
Measured: from enrollment to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start30 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdrenalectomyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOMINE-CRIQUI Claire, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110168
- Sponsor's protocol ID
- 2025PI122
- Acronym
- ROBADRE
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bihain F, Klein M, Nomine-Criqui C, Brunaud L. Robotic adrenalectomy in patients with pheochromocytoma: a systematic review. Gland Surg. 2020 Jun;9(3):844-848. doi: 10.21037/gs-2019-ra-05.
PubMed 32775278Giordano A, Balla A, Prosperi P, Morales-Conde S, Bergamini C. Robotic vs. Laparoscopic Adrenalectomy for Pheochromocytoma-A Systematic Review and Meta-Analysis. J Clin Med. 2025 May 29;14(11):3806. doi: 10.3390/jcm14113806.
PubMed 40507569Li X, Xiao S, Yu Y, Liu W, Xi H, Wang G, Zhou X. Robotic-assisted laparoscopic adrenalectomy (RARLA): What advantages and disadvantages compared to retroperitoneal laparoscopic adrenalectomy (RLA)? Front Endocrinol (Lausanne). 2023 Mar 2;14:1145820. doi: 10.3389/fendo.2023.1145820. eCollection 2023.
PubMed 36936166Chen Y, Scholten A, Chomsky-Higgins K, Nwaogu I, Gosnell JE, Seib C, Shen WT, Suh I, Duh QY. Risk Factors Associated With Perioperative Complications and Prolonged Length of Stay After Laparoscopic Adrenalectomy. JAMA Surg. 2018 Nov 1;153(11):1036-1041. doi: 10.1001/jamasurg.2018.2648.
PubMed 30090934Greilsamer T, Nomine-Criqui C, Thy M, Ullmann T, Zarnegar R, Bresler L, Brunaud L. Robotic-assisted unilateral adrenalectomy: risk factors for perioperative complications in 303 consecutive patients. Surg Endosc. 2019 Mar;33(3):802-810. doi: 10.1007/s00464-018-6346-2. Epub 2018 Jul 11.
PubMed 29998394
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Adrenalectomy, a Retrospective Single-center Study of 700 Procedures.
- ClinicalTrials.gov ID
- NCT07110168
- Acronym / sponsor ID
- ROBADRE / 2025PI122
- Conditions
- Adrenalectomy
- Keywords
- adrenalectomy, robotic surgery, robot-assisted surgery, transperitoneal adrenalectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 Aug 2025 (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.
To date, laparoscopy is considered to be the gold standard technique for adrenalectomy. Robotic surgery is beginning to be used, but no series of more than 300 procedures has yet allowed the morbidity, benefits and learning curve of this technique to be assessed. Furthermore, the debate on the benefits of using robotic tools when performing adrenalectomies remains open. At Nancy University Hospital, we have been performing robotic procedures on 90% of our patients since 2009, and have seen a significant increase in patient numbers (currently between 80 and 90 per year).
In 2019, we published a series of 300 patients, describing the results of the technique.
Based on our clinical experience and the growing interest of the surgical community, we believe that describing our cohort of patients who have undergone robot-assisted surgery (estimated at 600 patients) is of unquestionable scientific interest.
In 2018, the American team at UCLA published a series of 640 laparoscopic adrenalectomies and examined the risk factors for complications following this surgery. Given the team's reputation and their publication in the leading surgical journal (JAMA Surgery), we used the same criteria for our data collection to make our results comparable.
This study aims to evaluate the risk factors for surgical complications after robotic adrenalectomy in a large retrospective series. Our aim is to demonstrate the safety and reliability of this technique and to identify patients at greatest risk of complications. This may encourage the adoption of the technique in other centres.
Detailed description
Main objective:Evaluation of postoperative morbidity (Clavien-Dindo >2) 30 days after robot-assisted unilateral adrenalectomy
Secondary objective(s):
- Identify risk factors associated with the occurrence of complications after surgery. (patients characteristics, adrenal disease type)
- Determine the learning curve of robotic adrenalectomy considering surgical morbidity (Clavien Dindo>2)
- Determine the learning curve of robotic adrenalectomy considering operative time
Data collection:
PREOPERATIVE
Adrenal disease :
- Conn's adenoma
- Pheochromocytoma
- Cushing's adenoma
- Non-secreting adenoma
- Metastases (specify primary site: kidney, lung, skin)
- Virilising tumour
- Adrenal cancer (adrenocortical carcinoma)
- Haematological disorders
- Other
Patient characteristics:
- Age
- BMI
- ASA score
- Sex
- Comorbidity (Charleston score?)
- History of abdominal surgery/specify the procedure, noting whether it was laparoscopic or laparotomy
- History of adrenal surgery
- Genetic disease: NEM, VHL, etc.
Intra-operative data :
- Preoperative blood pressure
- Tumour laterality
- Surgeon
- Operative time
- Perioperative complications: bleeding, digestive tract injury, etc. ( using the KAARAFANI classification)
- Conversion to laparotomy and cause: adhesions, bleeding, digestive tract injury
Post-operative data :
- Length of hospital stay in days
- Morbidity: complications within 30 days after surgery according to Clavien-Dindo
- Mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent robot assisted adrenalectomy in University Hospital of Nancy | – | –All patients who underwent a robotic adrenalectomy (all adrenal disease included) in the Department of Visceral,Metabolic and Oncologic surgery in University Hospital of Nancy between 01.01.2013 and 12.31.2025. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent robot-assisted adrenalectomy in Department of Visceral Metabolic and Oncologic surgery Department
Key inclusion criteria (1 listed)
- all patient who underwent unilateral robot-assisted adrenalectomy
Key exclusion criteria (3 listed)
- bilateral adrenalectomy
- adrenalectomy by laparotomy
- partial adrenalectomy
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
Morbidity after robotic adrenalectomy
Time frame: from enrollment to 30 days after surgery
evaluation of morbidity after robotic adrenalectomy in the 30 days after surgery using Clavien Dindo classification
3 secondary outcomes
factors associated with clavien Dindo morbidity>2
Time frame: from enrollment to 30 days after surgery
Learning curve
Time frame: from enrollment to 30 days after surgery
Learning curve - operative time
Time frame: from enrollment to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Results publication: PubMed 32775278Bihain F, Klein M, Nomine-Criqui C, Brunaud L. Robotic adrenalectomy in patients with pheochromocytoma: a systematic review. Gland Surg. 2020 Jun;9(3):844-848. doi: 10.21037/gs-2019-ra-05.
- Results publication: PubMed 40507569Giordano A, Balla A, Prosperi P, Morales-Conde S, Bergamini C. Robotic vs. Laparoscopic Adrenalectomy for Pheochromocytoma-A Systematic Review and Meta-Analysis. J Clin Med. 2025 May 29;14(11):3806. doi: 10.3390/jcm14113806.
- Results publication: PubMed 36936166Li X, Xiao S, Yu Y, Liu W, Xi H, Wang G, Zhou X. Robotic-assisted laparoscopic adrenalectomy (RARLA): What advantages and disadvantages compared to retroperitoneal laparoscopic adrenalectomy (RLA)? Front Endocrinol (Lausanne). 2023 Mar 2;14:1145820. doi: 10.3389/fendo.2023.1145820. eCollection 2023.
- Results publication: PubMed 30090934Chen Y, Scholten A, Chomsky-Higgins K, Nwaogu I, Gosnell JE, Seib C, Shen WT, Suh I, Duh QY. Risk Factors Associated With Perioperative Complications and Prolonged Length of Stay After Laparoscopic Adrenalectomy. JAMA Surg. 2018 Nov 1;153(11):1036-1041. doi: 10.1001/jamasurg.2018.2648.
- Results publication: PubMed 29998394Greilsamer T, Nomine-Criqui C, Thy M, Ullmann T, Zarnegar R, Bresler L, Brunaud L. Robotic-assisted unilateral adrenalectomy: risk factors for perioperative complications in 303 consecutive patients. Surg Endosc. 2019 Mar;33(3):802-810. doi: 10.1007/s00464-018-6346-2. Epub 2018 Jul 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Central Hospital, Nancy, France at 1 site in France.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity after robotic adrenalectomy (time frame: from enrollment to 30 days after 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 NCT07110168, which also lists 5 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 7 Aug 2025.