Robotic Surgical ProceduresNCT03111797
Robot-assisted Lobectomy Versus Video-assisted Lobectomy
An observational study of Robotic Surgical Procedures and Pneumonectomy; Status, run by Hospital Nord at 1 site in France.
Trial summary
This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Surgical Procedures, Pneumonectomy; Status, Anesthesia and Analgesia
- What is being tested?
- Morphine and Cardiac output measure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 30 May 2017
- Phase
- Observational
- 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
Study population: All patients needing a lung lobectomy surgery for an early stage cancer in our center during the period of inclusion.
Who may be able to join
- Volunteers
- Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
- Video or robot assisted procedure
Who cannot join
- Advanced stage of cancer (T3Nx and greater)
- Need of thoracotomy conversion during procedure
- Morphine intolerance or addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study
This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.
Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output
All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.
- Conditions
- Robotic Surgical Procedures, Pneumonectomy; Status, Anesthesia and Analgesia, Cardiac Output
- Being tested
- Morphine, Cardiac output measure
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
we observe the self-patient controlled morphine consumption during the first 48h after surgery
Cardiac output measureOther
we observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory )
| Study group | Role | What they receive |
|---|---|---|
| video-assisted lobectomy group | patients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure Receives: Drug: Morphine; Other: Cardiac output measure | |
| robot-assisted lobectomy group | patients operated of lung lobectomy for an early stage cancer using a robot-assisted surgical procedure Receives: Drug: Morphine; Other: Cardiac output measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
morphine consumption for each patient using a self patient - controled morphine pump
Measured: 48 hours after surgery
Secondary outcomes (1)
cardiac output
continuous cardiac output during surgery procedure
Measured: during 30 minutes after incision and optic introduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Jan 2016
- Primary completion30 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Gary DUCLOS (Medical Doctor, investigator)
- Responsible party
- Principal investigator, marc LEONE, Hospital Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111797
- Sponsor's protocol ID
- darnord2017-02
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2017
- Last updated
- 22 Apr 2020
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03111797
- Acronym / sponsor ID
- darnord2017-02
- Conditions
- Robotic Surgical Procedures, Pneumonectomy; Status, Anesthesia and Analgesia, Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital NordUniversity, hospital or other
- Collaborators
- Gary DUCLOS (Medical Doctor, investigator)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 13 Apr 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.
This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.
Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output
All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-assisted lobectomy group | – | Drug: Morphine, Other: Cardiac output measurepatients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure |
| robot-assisted lobectomy group | – | Drug: Morphine, Other: Cardiac output measurepatients operated of lung lobectomy for an early stage cancer using a robot-assisted surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients needing a lung lobectomy surgery for an early stage cancer in our center during the period of inclusion.
Key inclusion criteria (3 listed)
- Volunteers
- Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
- Video or robot assisted procedure
Key exclusion criteria (3 listed)
- Advanced stage of cancer (T3Nx and greater)
- Need of thoracotomy conversion during procedure
- Morphine intolerance or addiction.
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 |
|---|---|---|
| Morphinewe observe the self-patient controlled morphine consumption during the first 48h after surgery | Drug | robot-assisted lobectomy group, video-assisted lobectomy group |
| Cardiac output measurewe observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory ) | Other | robot-assisted lobectomy group, video-assisted lobectomy group |
Primary outcome
Morphine consumption
Time frame: 48 hours after surgery
morphine consumption for each patient using a self patient - controled morphine pump
1 secondary outcome
cardiac output
Time frame: during 30 minutes after incision and optic introduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedures and Pneumonectomy; Status, run by Hospital Nord at 1 site in France.
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: finished, as of the sponsor's last update on 22 Apr 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 48 hours after surgery). 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 22 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.