NCT02928003

Brief Summary

Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable pain

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

October 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

October 5, 2016

Last Update Submit

August 13, 2019

Conditions

Pain

Keywords

Lung surgery

Outcome Measures

Primary Outcomes (1)

  • Number of patients with chronic pain 4 months after surgery

    4 months

Study Arms (1)

Lung Surgery

EXPERIMENTAL
Procedure: Lung surgery

Interventions

Lung surgeryPROCEDURE

Genetic analysis and questionnaires

Lung Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing lung resection surgery.
  • years and older (without superior limit);
  • Affiliated to french "securité sociale"

You may not qualify if:

  • Emergency procedure
  • litigation or search for compensation;
  • Previous intervention in the same region;
  • Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis …) that may interfere with the evaluation of the post-operative pain
  • Participation in another biomedical research protocol if there is an incompatibility with the present protocol.
  • mental disability
  • vulnerable person within the meaning of French law,
  • poor understanding of French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Mutualiste Montsouris

Paris, 750014, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pain

Interventions

Pulmonary Surgical Procedures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mireille Michel-Cherqui, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 7, 2016

Study Start

July 10, 2017

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)