Changes in Pleural Cavity Volume and Surgical Exposure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer
• Intervention / Treatment: Procedure: Diaphragmatic traction-suture

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Dept Cardiothorcic Surgery, Odense University Hospital
    • Contact: Peter B Licht, MD PhD; Phone Number: +45 65411831; Email: peter.licht@rsyd.dk
    • Principal Investigator: Peter B Licht, MD PhD
    • Sub-Investigator: Finn Dittberner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Before pulling diaphragmatic suture; Measurement of pleural cavity volume and visual overview before pulling diaphragmatic suture	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
Experimental: After pulling diaphragmatic suture; Measurement of pleural cavity volume and visual overview after pulling diaphragmatic suture	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleural cavity volume before	Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.	1 minute after applying the traction suture
Pleural cavity volume after	Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.	2 minute after applying the traction suture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Odense University Hospital

Publications and helpful links

General Publications

• Dittberner FA, Ladegaard L, Licht PB. A Diaphragmic Traction Suture Increases Pleural Cavity Volume and Surgical Field Overview During Video-Assisted Thoracoscopic Surgery. World J Surg. 2022 Jan;46(1):259-264. doi: 10.1007/s00268-021-06329-4. Epub 2021 Sep 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20/44867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No