Robot-assisted Adrenalectomy, a Retrospective Single-center Study of 700 Procedures.
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
- 否
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
NOMINE-CRIQUI Claire
Medical Doctor - Head of the endocrine surgery unit of the department of metabolic, endocrine and oncologic surgery
Central Hospital, Nancy, France
