跳至主要内容
临床试验/NCT07110168
NCT07110168进行中(未招募)不适用

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

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2025年5月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
700
试验地点
1
主要终点
Morbidity after robotic adrenalectomy

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patient who underwent unilateral robot-assisted adrenalectomy

排除标准

  • bilateral adrenalectomy
  • adrenalectomy by laparotomy
  • partial adrenalectomy

结局指标

主要结局

Morbidity after robotic adrenalectomy

时间窗: from enrollment to 30 days after surgery

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

次要结局

  • 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)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

NOMINE-CRIQUI Claire

Medical Doctor - Head of the endocrine surgery unit of the department of metabolic, endocrine and oncologic surgery

Central Hospital, Nancy, France

研究点 (1)

Loading locations...

相似试验