Changes in Pleural Cavity Volume and Surgical Exposure

Not Applicable

• Conditions: Thoracic Cancer
• Interventions: Procedure: Diaphragmatic traction-suture

• Registration Number: NCT04837950
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2020-11-09
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
After pulling diaphragmatic suture	Diaphragmatic traction-suture	Measurement of pleural cavity volume and visual overview after pulling diaphragmatic suture
Before pulling diaphragmatic suture	Diaphragmatic traction-suture	Measurement of pleural cavity volume and visual overview before pulling diaphragmatic suture

Primary Outcome Measures

Name	Time	Method
Pleural cavity volume after	2 minute after applying the traction suture	Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.
Pleural cavity volume before	1 minute after applying the traction suture	Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.

Secondary Outcome Measures

Name	Time	Method
Visual overview	1 minute after applying the traction suture	The surgeon's evaluation of the surgical field visual overview before and after distal retraction of the diaphragmatic traction suture using a numeric rating scale (1-10).

Trial Locations

Locations (1)

Dept Cardiothorcic Surgery, Odense University Hospital; 🇩🇰 Odense, Denmark