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临床试验/NCT06806280
NCT06806280招募中不适用

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

Göteborg University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月17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
80
试验地点
1
主要终点
Forced vital capacity, FVC

研究概览

简要总结

The study will investigate how respiratory function is affected by robot-assisted surgery. Previous studies have investigated the impact after open and laparoscopic surgery, but there are no studies yet after robot-assisted surgery.

80 women undergoing robot-assisted hysterectomy will undergo measurements of lung function and oxygen saturation before and after the operation.

详细描述

It is well known that respiration is affected during surgery under general anesthesia. Despite optimal ventilation in a respirator during the procedure, lung volume decreases, leading to atelectasis. Other effects include increased secretions in the airways, while ciliary function deteriorates. After surgery performed under general anesthesia, the patient therefore often develops hypoventilation. This can largely be explained by lingering effects of anesthetics, reduced lung volumes, atelectasis, pain and immobilization.

In a previous study, lung effects have been studied in open and laparoscopic surgery, including after hysterectomy. With the development of robotic surgery and operations on patients with an increasing number of risk factors, complementary studies are needed.

The aim of the study is to investigate changes in lung function during robot-assisted laparoscopic surgery due to uterine cancer or endometrial intraepithelial neoplasia in the uterus, and to search for predictors of low lung volume, hypoxia and pneumonia.

A consecutive series of 80 patients undergoing robot-assisted hysterectomy will be included in the study.

At the preoperative visit, a dynamic spirometry (Easyone, ndd, Medical Technologies, Switzerland) is performed in a sitting position according to international guidelines. Before the test, oxygen saturation will be measured with a finger probe. In addition, patients will assess their lung function on a visual analogue scale

研究设计

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

入排标准

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

入选标准

  • •≥18 years of age undergoing robotic-assisted laparoscopic hysterectomy for endometrial cancer or endometrial intraepitelial neoplasty..

排除标准

  • •cognitive impairment and difficulty understanding Swedish or English instructions.

结局指标

主要结局

Forced vital capacity, FVC

时间窗: Up to the first day after surgery

A spirometry including FVC will be performed in the sitting position according to international guidelines.

次要结局

  • Oxygen saturation(Up to the first day after surgery)
  • Forced expiratory volume during one second, FEV1(Up to the first day after surgery)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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