Changes in Pleural Cavity Volume and Surgical Exposure

NCT ID: NCT04837950

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Thoracic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Volume of saline in pleural cavity and surgical field overview before and after pulling traction suture

Study Groups

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Before pulling diaphragmatic suture

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

Group Type EXPERIMENTAL

Diaphragmatic traction-suture

Intervention Type 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

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

Group Type EXPERIMENTAL

Diaphragmatic traction-suture

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter B Licht

MD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept Cardiothorcic Surgery, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Peter B Licht, MD PhD

Role: primary

+45 65411831

References

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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.

Reference Type DERIVED
PMID: 34586461 (View on PubMed)

Other Identifiers

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20/44867

Identifier Type: -

Identifier Source: org_study_id

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