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Robot-assisted Adrenalectomy, Feasibility and Results

Robot-assisted Adrenalectomy, a Retrospective Single-center Study of 700 Procedures.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07110168
Acronym
ROBADRE
Enrollment
700
Registered
2025-08-07
Start date
2025-05-30
Completion date
2026-08-30
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenalectomy

Keywords

adrenalectomy, robotic surgery, robot-assisted surgery, transperitoneal adrenalectomy

Brief 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. 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

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patient who underwent unilateral robot-assisted adrenalectomy

Exclusion criteria

* bilateral adrenalectomy * adrenalectomy by laparotomy * partial adrenalectomy

Design outcomes

Primary

MeasureTime frameDescription
Morbidity after robotic adrenalectomyfrom enrollment to 30 days after surgeryevaluation of morbidity after robotic adrenalectomy in the 30 days after surgery using Clavien Dindo classification

Secondary

MeasureTime frameDescription
factors associated with clavien Dindo morbidity>2from enrollment to 30 days after surgeryUsing the data base, identification of factors related to patient or to adrenal disease associated with a higher post-operative morbidity
Learning curvefrom enrollment to 30 days after surgeryTo determinate the learning curve of robotic adrenalectomy with a significant decrease of post-operative morbidity (number of cases)
Learning curve - operative timefrom enrollment to 30 days after surgeryTo determinate the number of procedure necessary to significantly decrease the operative time

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026