Robot-assisted Lobectomy Versus Video-assisted Lobectomy

NCT03111797 | Completed

• 1 other identifier: darnord2017-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Robotic Surgical Procedures; Pneumonectomy; Status; Anesthesia and Analgesia; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  morphine consumption for each patient using a self patient - controled morphine pump

  48 hours after surgery

Secondary Outcomes (1)

• cardiac output

  during 30 minutes after incision and optic introduction

Study Arms (2)

video-assisted lobectomy group

patients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure

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

Drug: Morphine; Other: Cardiac output measure

Interventions

Morphine DRUG

we observe the self-patient controlled morphine consumption during the first 48h after surgery

robot-assisted lobectomy group; video-assisted lobectomy group

Cardiac output measure OTHER

we observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory )

robot-assisted lobectomy group; video-assisted lobectomy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients needing a lung lobectomy surgery for an early stage cancer in our center during the period of inclusion.

You may qualify if:

• Volunteers
• Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
• Video or robot assisted procedure

You may not qualify if:

• Advanced stage of cancer (T3Nx and greater)
• Need of thoracotomy conversion during procedure
• Morphine intolerance or addiction.

Sponsors & Collaborators

• Hospital Nord: lead
• Gary DUCLOS (Medical Doctor, investigator): collaborator

Study Sites (1)

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director, Clinical professor

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 13, 2017
• Study Start: January 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)