Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-26 @ 8:57 AM
Study NCT ID:
NCT07110168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-assisted Adrenalectomy, Feasibility and Results
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Robot-assisted Adrenalectomy, a Retrospective Single-center Study of 700 Procedures.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROBADRE
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: