NCT07110168

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2025Aug 2026

Study Start

First participant enrolled

May 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

adrenalectomyrobotic surgeryrobot-assisted surgerytransperitoneal adrenalectomy

Outcome Measures

Primary Outcomes (1)

  • Morbidity after robotic adrenalectomy

    evaluation of morbidity after robotic adrenalectomy in the 30 days after surgery using Clavien Dindo classification

    from enrollment to 30 days after surgery

Secondary Outcomes (3)

  • factors associated with clavien Dindo morbidity>2

    from enrollment to 30 days after surgery

  • Learning curve

    from enrollment to 30 days after surgery

  • Learning curve - operative time

    from enrollment to 30 days after surgery

Study Arms (1)

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent robot-assisted adrenalectomy in Department of Visceral Metabolic and Oncologic surgery Department

You may qualify if:

  • all patient who underwent unilateral robot-assisted adrenalectomy

You may not qualify if:

  • bilateral adrenalectomy
  • adrenalectomy by laparotomy
  • partial adrenalectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nomine-Criqui Claire

Nancy, Lorraine, 54000, France

Location

Related Publications (5)

  • 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.

    PMID: 32775278BACKGROUND
  • Giordano 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.

    PMID: 40507569BACKGROUND
  • Li 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.

    PMID: 36936166BACKGROUND
  • Chen 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.

    PMID: 30090934BACKGROUND
  • Greilsamer 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.

    PMID: 29998394BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor - Head of the endocrine surgery unit of the department of metabolic, endocrine and oncologic surgery

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

May 30, 2025

Primary Completion

August 30, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Locations