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NCT04837950 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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