NCT02237963

Brief Summary

The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

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

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

September 9, 2014

Last Update Submit

October 28, 2016

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

    Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)

    4 months

Secondary Outcomes (6)

  • Early postoperative pain

    7 days

  • Characteristics of chronic pain

    4 months

  • Quality of life

    4 months

  • Catastrophism

    4 months

  • Anxiety

    4 months

  • +1 more secondary outcomes

Study Arms (2)

Posterolateral thoracotomy

Surgeons perform a posterolateral thoracotomy

Procedure: Posterolateral thoracotomy

Axillary thoracotomy

Surgeons perform an axillary thoracotomy

Procedure: Axillary thoracotomy

Interventions

Posterolateral thoracotomyPROCEDURE
Posterolateral thoracotomy
Axillary thoracotomyPROCEDURE
Axillary thoracotomy

Eligibility Criteria

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

Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

You may not qualify if:

  • planned surgery by thoracoscopy or extended surgery,
  • mental disability,
  • vulnerable person within the meaning of French law,
  • inability to communicate by phone,
  • poor understanding of French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (1)

  • Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.

    PMID: 23370071BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mireille Michel-Cherqui, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)