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Clinical Trials/NCT02829736
NCT02829736
Unknown
Not Applicable

Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study

Rigshospitalet, Denmark1 site in 1 country90 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Rigshospitalet, Denmark
Enrollment
90
Locations
1
Primary Endpoint
Pain
Last Updated
8 years ago

Overview

Brief Summary

Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.

Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
August 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bo Laksáfoss Holbek

Medical doctor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Elective thoracoscopic wedge resection
  • Speaks and understands Danish
  • FEV1 \>= 60% of expected

Exclusion Criteria

  • Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
  • Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
  • Air leak on intraoperative sealing test
  • Patients previously included in study
  • Planned intraoperative frozen section with possible lobectomy
  • Previously included in current study
  • Planned frozen section diagnostics
  • Previous ipsilateral anatomic lung resection

Outcomes

Primary Outcomes

Pain

Time Frame: Through post-operative admission, an average of 1 day.

Average pain expressed as area under the curve from a numeric rank score at 1, 3, 6 and 9 hours after surgery as well as daily at 8 am and 8 pm from post-operative day 1 until discharge.

Secondary Outcomes

  • Reasons for post-operative admission(Through post-operative admission, an average of 1 day.)
  • Pneumothorax(Up to post-operative day 1.)
  • Lung function(Up to post-operative day 1.)
  • Reinsertion of chest tubes(Up to post-operative day 30.)
  • Complications(Up to post-operative day 30.)

Study Sites (1)

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