Changes in Pleural Cavity Volume and Surgical Exposure

NCT04837950 | Unknown

• 1 other identifier: 20/44867
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual overview

  1 minute after applying the traction suture

Study Arms (2)

Before pulling diaphragmatic suture

EXPERIMENTAL

Measurement of pleural cavity volume and visual overview before pulling diaphragmatic suture

Procedure: Diaphragmatic traction-suture

After pulling diaphragmatic suture

EXPERIMENTAL

Measurement of pleural cavity volume and visual overview after pulling diaphragmatic suture

Procedure: Diaphragmatic traction-suture

Interventions

Diaphragmatic traction-suture PROCEDURE

Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture

After pulling diaphragmatic suture; Before pulling diaphragmatic suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Dept Cardiothorcic Surgery, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 34586461 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Volume of saline in pleural cavity and surgical field overview before and after pulling traction suture
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Professor

Model Details: During video-assisted thoracoscopic surgery a diaphragmatic traction-suture is placed posteriorly at the border between the central tendinous part and the peripheral muscular part. Body temperate saline solution is then poured into the pleural cavity until the cavity is filled up to the soft-tissue retractor in the utility port. The volume of saline in the pleural cavity is then measured and registered before and after distal contraction of the diaphragmatic traction suture through the camera port. Subsequently the surgeon will be asked to evaluate and rate the surgical field visual overview, before and after contraction of the suture. Furthermore, anonymized video recordings focusing on the pleural cavity visual overview before and after distal contraction of the suture, will be presented to specialist thoracic surgeons for a blinded evaluation.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: April 8, 2021
• Study Start: September 29, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)