Lung CancerNCT03152071
Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer
A study testing Robot assited thoracic surgery and Video assited thoracic surgery in people with Lung Cancer and Postoperative Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer. The perioperative circumstances and postoperative outcome will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Postoperative Pain, Blood Loss
- What is being tested?
- Robot assited thoracic surgery and Video assited thoracic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2017to 1 Jul 2018
- 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
- Patients must be 18 years old or older
- Patients can be male or female
- Patients with a lung tumour which is treatable with surgery
Who cannot join
- Pregnancy
- Inoperable lung tumour
- Patients which are at risk for general anaesthesia
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Dirk Smets, MD, dirk.smets@uzbrussel.be
Wietske Renckens, meMD, wietske.renckens@vub.be
About this study
Official title: Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group
In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.
The perioperative circumstances and postoperative outcome will be compared.
Read the detailed description
Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage.
The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).
- Conditions
- Lung Cancer, Postoperative Pain, Blood Loss, Inflammatory Response
- Being tested
- Robot assited thoracic surgery, Video assited thoracic surgery
- Keywords
- thoracoscopic surgery, RATS, VATS, Robot
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assited thoracic surgeryProcedure or surgery
Also called RATS
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery
Video assited thoracic surgeryProcedure or surgery
Also called VATS
The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted thoracic surgery | Experimental | RATS Receives: Procedure: Video assited thoracic surgery |
| Video assisted thoracic surgery | Active comparator | VATS Receives: Procedure: Robot assited thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
0 = no pain 10 = unbearable pain: VASscore
Measured: 2 months
Secondary outcomes (9)
blood loss
ml
Measured: up to 4 hours
operative time
duration of surgery
Measured: up to 4 hours
conversion to spreading of the ribs/thoracotomy
0 = no 1 = yes
Measured: up to 4 hours
lymph node dissection
number of lymph nodes
Measured: up to 4 hours
prolonged air leak
chest tube present longer than usual
Measured: up to 7 days
chest tube drainage
ml
Measured: up to 7 days
length of stay
duration of hospitalisation after surgery
Measured: up to 7 days
pulmonary function
recovery of function of the operated lung
Measured: 2 months
Inflammatory reaction
these inflammatory parameters will be determined: C-reactive protein; IL-3; IL-6; TNF
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start15 Aug 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Wietske Renckens, MD, Study chair, Universitair Ziekenhuis BrusselDirk Smets, MD, Principal investigator, Universitair Ziekenhuis BrusselEef Vanderhelst, MD, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152071
- Sponsor's protocol ID
- RATS vs VATS
- Status last verified
- Oct 2017
- First submitted
- 9 May 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group
- ClinicalTrials.gov ID
- NCT03152071
- Acronym / sponsor ID
- RATS vs VATS
- Conditions
- Lung Cancer, Postoperative Pain, Blood Loss, Inflammatory Response
- Keywords
- thoracoscopic surgery, RATS, VATS, Robot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 12 May 2017 (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.
In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.
The perioperative circumstances and postoperative outcome will be compared.
Detailed description
Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage.
The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted thoracic surgery | Experimental | Procedure: Video assited thoracic surgeryRATS |
| Video assisted thoracic surgery | Active comparator | Procedure: Robot assited thoracic surgeryVATS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 years old or older
- Patients can be male or female
- Patients with a lung tumour which is treatable with surgery
Key exclusion criteria (3 listed)
- Pregnancy
- Inoperable lung tumour
- Patients which are at risk for general anaesthesia
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 |
|---|---|---|
| Robot assited thoracic surgeryAlso: RATSThe lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery | Procedure or surgery | Video assisted thoracic surgery |
| Video assited thoracic surgeryAlso: VATSThe lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery. | Procedure or surgery | Robot assisted thoracic surgery |
Primary outcome
Postoperative pain
Time frame: 2 months
0 = no pain 10 = unbearable pain: VASscore
9 secondary outcomes
blood loss
Time frame: up to 4 hours
operative time
Time frame: up to 4 hours
conversion to spreading of the ribs/thoracotomy
Time frame: up to 4 hours
lymph node dissection
Time frame: up to 4 hours
prolonged air leak
Time frame: up to 7 days
chest tube drainage
Time frame: up to 7 days
length of stay
Time frame: up to 7 days
pulmonary function
Time frame: 2 months
Inflammatory reaction
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- 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.
Wietske Renckens, MD study chair
Universitair Ziekenhuis Brussel
Dirk Smets, MD principal investigator
Universitair Ziekenhuis Brussel
Eef Vanderhelst, MD study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assited thoracic surgery and Video assited thoracic surgery in people with Lung Cancer and Postoperative Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 9 Oct 2017. 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 Belgium. 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?
Contact Veerle Van Mossevelde, data nurse (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2017.