Robot-assisted Lobectomy Versus Video-assisted Lobectomy

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.

Study Overview

• Status: Completed
• Conditions: Robotic Surgical Procedures; Anesthesia and Analgesia; Cardiac Output; Pneumonectomy; Status
• Intervention / Treatment: Drug: Morphine; Other: Cardiac output measure

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Departement anesthesie reanimation hopital nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
video-assisted lobectomy group; patients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure	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 )
robot-assisted lobectomy group; patients operated of lung lobectomy for an early stage cancer using a robot-assisted surgical procedure	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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	morphine consumption for each patient using a self patient - controled morphine pump	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output	continuous cardiac output during surgery procedure	during 30 minutes after incision and optic introduction

Collaborators and Investigators

• Sponsor: Hospital Nord
• Collaborators: Gary DUCLOS (Medical Doctor, investigator)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: April 8, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: darnord2017-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No