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NCT03111797 Clinical Trial

Robot-assisted Lobectomy Versus Video-assisted Lobectomy

Cardiac Output Clinical Trial

Official title:
Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03111797
Other study ID # darnord2017-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date May 30, 2017

Study information
Verified date April 2020
Source Hospital Nord
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 30, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Volunteers

- Mono lobectomy of lung for early stage cancer (T2Nx and earlier)

- Video or robot assisted procedure

Exclusion Criteria:

- Advanced stage of cancer (T3Nx and greater)

- Need of thoracotomy conversion during procedure

- Morphine intolerance or addiction.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Morphine
we observe the self-patient controlled morphine consumption during the first 48h after surgery
Other:
• Cardiac output measure
we observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory )

Locations
Country Name City State
France Departement anesthesie reanimation hopital nord Marseille

Sponsors (2)
Lead Sponsor Collaborator
Hospital Nord Gary DUCLOS (Medical Doctor, investigator)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Morphine consumption morphine consumption for each patient using a self patient - controled morphine pump 48 hours after surgery
Secondary cardiac output continuous cardiac output during surgery procedure during 30 minutes after incision and optic introduction
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