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临床试验/NCT06496386
NCT06496386招募中不适用

Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study

Scientific Institute San Raffaele2 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2024年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
386
试验地点
2
主要终点
The perioperative complications

研究概览

简要总结

The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.

There are no risks for the patients, as this is a retrospective data collection.

详细描述

The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.

Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).

the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Age >18 years at the moment of surgery
  • Suspected or confirmed diagnosis of lung cancer
  • The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
  • Absence of extrapulmonary metastases that are not controlled or controllable
  • All procedures included use of DaVinci robot system

排除标准

  • Age < 18 years at the moment of surgery
  • Patients who cannot undergo surgery, as they do not meet the conditions outlined above

结局指标

主要结局

The perioperative complications

时间窗: from the surgery at 30-90 days after

the investigators will measure the perioperative complications of robotic lung resection in patients with 80 or more than 80 years (very elderly patients) compared to those with less than 80 years. Complications will be categorized according to the Clavien-Dindo scale.

spirometry tests

时间窗: from hospitalizzation to the discharge date at maximum one week

the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups .

Postoperative hospital stay

时间窗: from hospitalizzation to the discharge date at maximum one week

the investigators will measure the post-operative hospital stay in days in the two groups.

次要结局

未报告次要终点

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierluigi Novellis

Medical doctor

Scientific Institute San Raffaele

研究点 (2)

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