Changes in Pleural Cavity Volume and Surgical Exposure

Thoracic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837950
• Other study ID #: 20/44867
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• known or suspected lung cancer

• scheduled for VATS-surgery

• perioperative finding of elevated diaphragma

Exclusion Criteria:

• not willing to give informed consent.

• perioperative finding of pleural adherences

• perioperative finding without an elevated diaphragma

Related Conditions & MeSH terms

• Thoracic Cancer

Intervention

Procedure:
• Diaphragmatic traction-suture
Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture

Locations

Country	Name	City	State
Denmark	Dept Cardiothorcic Surgery, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleural cavity volume before	Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.	1 minute after applying the traction suture
Primary	Pleural cavity volume after	Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.	2 minute after applying the traction suture
Secondary	Visual overview	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).	1 minute after applying the traction suture