Acute and Chronic Pain in Lung Transplantation: Prevalenc... | NCT02897882

Studies
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care

NCT02897882

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

May 22, 2017Actual

Enrollment

94Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Lung transplant

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A01353-54	Other Identifier	ANSM

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010Actual

Primary Completion Date

Apr 27, 2017Actual

Completion Date

Apr 27, 2017Actual

First Submitted Date

Aug 31, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2017

Last Update Posted Date

May 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung transplant	Experimental	Pain evaluation	Other: Lung transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung transplant	Other	Pain evaluation	Lung transplant

Measure	Description	Time Frame
Chronic pain measured by a digital scale		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients benefiting from a lung transplant
Patients on a list for a lung transplant from may 2010

Exclusion Criteria:

Patients refusing to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, PhD	Hopital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92150	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016040	Lung Transplantation

Ancestor Terms

ID	Term
D013510	Pulmonary Surgical Procedures
D019616	Thoracic Surgical Procedures
D013514	Surgical Procedures, Operative
D016377	Organ Transplantation

Browse Leaves

Not provided

Browse Branches

Not provided