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临床试验/NCT04837950
NCT04837950Unknown不适用

Changes in Pleural Cavity Volume and Surgical Exposure Through Suture Retraction of the Diaphragm During VATS Procedures

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Pleural cavity volume after

研究概览

简要总结

The investigators want to investigate if a diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

详细描述

A visually good surgical field is essential in performing safe and optimal dissection of anatomical structures during Video Assisted Thoracoscopic Surgery (VATS). A number of patients referred to VATS-surgery appear with an elevated diaphragm, reducing visibility and complicating safe surgical techniques, thus entailing conversion from VATS into an open Thoracotomy. Some surgeons handle the decreased visibility due to an elevated diaphragm by increasing the amount of ports during VATS. Others have benefited from attaching a traction suture on the diaphragmatic posterior tendinous part, thus flatting the diaphragmatic dome when the suture is tightly retracted through the camera-port. It turns out that most thoracic surgery clinics are not familiar with this technique. There are also no articles regarding this topic in medical literature. We want to investigate if the diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Volume of saline in pleural cavity and surgical field overview before and after pulling traction suture

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

  • known or suspected lung cancer
  • scheduled for VATS-surgery
  • perioperative finding of elevated diaphragma

排除标准

  • not willing to give informed consent.
  • perioperative finding of pleural adherences
  • perioperative finding without an elevated diaphragma

结局指标

主要结局

Pleural cavity volume after

时间窗: 2 minute after applying the traction suture

Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.

Pleural cavity volume before

时间窗: 1 minute after applying the traction suture

Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.

次要结局

  • Visual overview(1 minute after applying the traction suture)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter B Licht

MD Professor

Odense University Hospital

研究点 (2)

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