NCT00969423

Brief Summary

The study will investigate characteristics of chronic pain after VATS surgery with two different sizes of videoscopic equipment.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

2.2 years

First QC Date

August 31, 2009

Last Update Submit

August 17, 2011

Conditions

Pneumothorax

Keywords

persistent painneuropathic painChronic PainVATSPrimary spontaneous pneumothorax patients

Outcome Measures

Primary Outcomes (2)

  • QST score

    2 years

  • Post surgical pain

    2 years

Secondary Outcomes (1)

  • Patient related factors, depression, coping etc.

    2 years

Study Arms (2)

5 mm equipment

EXPERIMENTAL

5 mm videoscopic equipment

Device: 5mm videoscope

10 mm

EXPERIMENTAL

Use of standard 10 mm VATS equipment

Device: 10mm videoscope

Interventions

5mm videoscopeDEVICE

use of 5mm videoscope

5 mm equipment
10mm videoscopeDEVICE

use of 10mm videoscope

10 mm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PSP
  • Able to understand and give consent
  • Can read
  • Residing in Denmark

You may not qualify if:

  • Unable to understand the written information in Danish
  • Abuse (Medicine, Drugs, Alcohol)
  • Severe psychiatric Illness
  • Conflicting neurological disease
  • Conversion to open surgery
  • Use of neuroaxial analgesia
  • Use of electric cauterizer necessitated
  • Additional thoracic surgery in the investigation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, dk-2100, Denmark

Location

Related Publications (1)

  • Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.

    PMID: 19307137BACKGROUND

MeSH Terms

Conditions

PneumothoraxNeuralgiaChronic Pain

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kim Wildgaard, MD

    Section for Surgical Pathophysiology 4074 Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

DK(1)