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Recruiting NCT04670523

Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

No phase Interventional Lung Pathologies of Unclear Etiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early postoperative day 0 (POD 0) chest tube removal., Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1)..
Who it may be relevant to
Registry conditions: Lung Pathologies of Unclear Etiology. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.

Overview

The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Detailed description

Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Interventions

  • Procedure Early postoperative day 0 (POD 0) chest tube removal.
    Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If air
  • Procedure Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
    Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Primary outcome measures

  • 1. Pneumothorax requiring chest tube reinsertion [Time frame: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)]
  • 2. Pleural effusion requiring thoracocentesis [Time frame: Pleural effusion 2 hours after chest tube removal between POD 0 and 30]
  • 3. Prolonged air leak > 5 days [Time frame: Chest tube removal between POD 6 and 30]
  • 4. Re-admission or reoperation due to pleural complication [Time frame: Up to 1 month after first operation]
Secondary outcome measures (4)
  • 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) [Time frame: Up to 1 month after initial operation]
  • 2. Re-operation [Time frame: Up to 1 month after initial operation]
  • 3. Length of drainage (days) [Time frame: Up to 1 month after initial operation]
  • 4. Length of stay (days) [Time frame: Up to 1 month after initial operation]

Eligibility criteria

Inclusion criteria

  • Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
  • Thoracoscopic pleural biopsy
  • Signed consent
  • Age of majority

Exclusion criteria

  • Anatomical resection
  • Empyema
  • Pleural effusion
  • Pleurodesis
  • Vulnerable persons (Pregnant women, Children and adolescents)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital of Bern, Inselspital — Bern

Identifiers

NCT: NCT04670523 · EROCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗