NCT05126524

Brief Summary

Currently, there is no data on the part and type of Loco-regional Anaesthesia used for Video or Robot-assisted Thoracic Pulmonary Surgery. The aim of this epidemiological study is to identify, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations, the proportion and type of Loco-regional Anaesthesia used in Video or Robot-assisted Thoracic Pulmonary Surgery within French teams.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

November 8, 2021

Last Update Submit

April 11, 2023

Conditions

Keywords

Loco-regional AnaesthesiaVideo or Robot-assisted Thoracic Pulmonary SurgeryARTISTSFAR

Outcome Measures

Primary Outcomes (1)

  • to assess the incidence of locoregional anesthesia in video or robot-assisted thoracic pulmonary surgery

    Information concerning locoregional anesthesia in video or robot-assisted thoracic are recorder in the CRF

    At least, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations concerning this topic

Secondary Outcomes (2)

  • Epidemiology of anaesthesia management during Video or Robot-assisted Thoracic Pulmonary Surgery

    At least, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations concerning this topic

  • Epidemiology of perioperative morbidity and mortality

    At least, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations concerning this topic

Study Arms (1)

Loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery

Patients with loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery are eligible for this study

Other: NO INTERVENTION

Interventions

Observational study, no intervention performed

Loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with planned wedge surgery or lobectomy with Video or Robot assisted surgery

You may qualify if:

  • Male or female aged 18years and over
  • Wedge surgery or lobectomy planned with Video or Robot-assisted surgery.
  • non-opposition of the patient to participating in the research

You may not qualify if:

  • Patient's refusal to use his data for research
  • Emergency surgery
  • Surgery with planned thoracotomy
  • Contraindications to performing locoregional anesthesia
  • Individual deprived of liberty or placed under the authority of a tutor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CHU d'Angers

Angers, 49100, France

Location

Hôpital Privé d'Antony

Antony, 92160, France

Location

Clinique de l'Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69300, France

Location

centre de Lutte Contre le Cancer Jean Perrin

Clermont-Ferrand, 63011, France

Location

Chu Dijon

Dijon, 21000, France

Location

CHU de Grenoble

La Tronche, 38700, France

Location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHRU de Lille _Clinique Cardiothoracique et Vasculaire

Lille, 59000, France

Location

CHU Limoges

Limoges, 87000, France

Location

Centre Leon Bérard

Lyon, 69008, France

Location

Hôpital Nord Marseille

Marseille, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHRU de Nancy

Nancy, 54511, France

Location

CHU Nantes - Réa CTCV de l'HGR

Nantes, 44093, France

Location

CHR d'ORLEANS

Orléans, 45100, France

Location

Institut Mutualist Montsouris - Paris

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Hôpital TENON

Paris, 75020, France

Location

CHU de Poitiers

Poitiers, 83021, France

Location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

CHU de Rennes, Hôpital de Pontchaillou

Rennes, 35 033, France

Location

Polyclinique Saint Laurent

Rennes, 35700, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

Centre Hospitalier de Toulon

Toulon, 83000, France

Location

HIA Sainte-Anne - Toulon

Toulon, 83800, France

Location

Study Officials

  • Grégoire LE GAC, MD

    CHU de Rennes, Hôpital de Pontchaillou

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 19, 2021

Study Start

January 4, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations