Thoracic CancerNCT04837950
Changes in Pleural Cavity Volume and Surgical Exposure
A study testing Diaphragmatic traction-suture in people with Thoracic Cancer, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Cancer
- What is being tested?
- Diaphragmatic traction-suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Sep 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known or suspected lung cancer
- scheduled for VATS-surgery
- perioperative finding of elevated diaphragma
Who cannot join
- not willing to give informed consent.
- perioperative finding of pleural adherences
- perioperative finding without an elevated diaphragma
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept Cardiothorcic Surgery, Odense University Hospital
Odense, 5000
Peter B Licht, MD PhD, +45 65411831, peter.licht@rsyd.dk
Peter B Licht, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Cancer
- Being tested
- Diaphragmatic traction-suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic traction-sutureProcedure or surgery
Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture
| Study group | Role | What they receive |
|---|---|---|
| Before pulling diaphragmatic suture | Experimental | Measurement of pleural cavity volume and visual overview before pulling diaphragmatic suture Receives: Procedure: Diaphragmatic traction-suture |
| After pulling diaphragmatic suture | Experimental | Measurement of pleural cavity volume and visual overview after pulling diaphragmatic suture Receives: Procedure: Diaphragmatic traction-suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural cavity volume before
Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.
Measured: 1 minute after applying the traction suture
Pleural cavity volume after
Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.
Measured: 2 minute after applying the traction suture
Secondary outcomes (1)
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).
Measured: 1 minute after applying the traction suture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start29 Sep 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter B Licht, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837950
- Sponsor's protocol ID
- 20/44867
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34586461
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pleural Cavity Volume and Surgical Exposure Through Suture Retraction of the Diaphragm During VATS Procedures
- ClinicalTrials.gov ID
- NCT04837950
- Acronym / sponsor ID
- 20/44867
- Conditions
- Thoracic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Before pulling diaphragmatic suture | Experimental | Procedure: Diaphragmatic traction-sutureMeasurement of pleural cavity volume and visual overview before pulling diaphragmatic suture |
| After pulling diaphragmatic suture | Experimental | Procedure: Diaphragmatic traction-sutureMeasurement of pleural cavity volume and visual overview after pulling diaphragmatic suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- known or suspected lung cancer
- scheduled for VATS-surgery
- perioperative finding of elevated diaphragma
Key exclusion criteria (3 listed)
- not willing to give informed consent.
- perioperative finding of pleural adherences
- perioperative finding without an elevated diaphragma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic traction-sutureMeasurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture | Procedure or surgery | After pulling diaphragmatic suture, Before pulling diaphragmatic suture |
Primary outcome
Pleural cavity volume before
Time frame: 1 minute after applying the traction suture
Pleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.
Pleural cavity volume after
Time frame: 2 minute after applying the traction suture
Pleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.
1 secondary outcome
Visual overview
Time frame: 1 minute after applying the traction suture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 34586461Dittberner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept Cardiothorcic Surgery, Odense University Hospital
Odense, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic traction-suture in people with Thoracic Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural cavity volume before (time frame: 1 minute after applying the traction suture). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.