Clinical trial NCT04837950: Changes in Pleural Cavity Volume and Surgical Exposure
Official title: Changes in Pleural Cavity Volume and Surgical Exposure Through Suture Retraction of the Diaphragm During VATS Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pleural cavity volume before
timeFrame: 1 minute after applying the traction suture
measure: Pleural cavity volume after
timeFrame: 2 minute after applying the traction suture
Secondary outcomes:
measure: Visual overview
timeFrame: 1 minute after applying the traction suture
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Dept Cardiothorcic Surgery, Odense University Hospital
Study officials:
References:
citation: 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.