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NCT Number: NCT07110168

Robot-assisted Adrenalectomy, Feasibility and Results

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adrenalectomy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nomine-Criqui Claire

Nancy, Lorraine, 54000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patient who underwent unilateral robot-assisted adrenalectomy

Exclusion criteria

  • bilateral adrenalectomy
  • adrenalectomy by laparotomy
  • partial adrenalectomy

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. factors associated with clavien Dindo morbidity>2

    Time frame: from enrollment to 30 days after surgery

    Using the data base, identification of factors related to patient or to adrenal disease associated with a higher post-operative morbidity

  2. Learning curve

    Time frame: from enrollment to 30 days after surgery

    To determinate the learning curve of robotic adrenalectomy with a significant decrease of post-operative morbidity (number of cases)

  3. Learning curve - operative time

    Time frame: from enrollment to 30 days after surgery

    To determinate the number of procedure necessary to significantly decrease the operative time

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ROBADRE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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