ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

NCT02829736 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Pain
  • Decreased Lung Function
  • Delayed Discharge

Interventions

PROCEDURE

Intraoperative sealing test

A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.

PROCEDURE

Standard post-operative chest tube

A regular chest tube is left in the pleura.

PROCEDURE

Intraoperative chest tube removal

Chest tube is removed intraoperatively.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Henrik J. Hansen, MD · Rigshospitalet, Denmark

  • René H. Petersen, MD · Rigshospitalet, Denmark

  • Henrik Kehlet, DMSc · Rigshospitalet, Denmark

  • Bo L. Holbek, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-07-31
Completion
2018-08-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02829736 on ClinicalTrials.gov