Clinical trial NCT04670523: Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries
Official title: Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Pathologies of Unclear Etiology
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomization of patients after minor thoracic operations into two different groups. 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. If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1. In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
2. Thoracoscopic pleural biopsy
3. Signed consent
4. Age of majority

Exclusion Criteria:

1. Anatomical resection
2. Empyema
3. Pleural effusion
4. Pleurodesis
5. Vulnerable persons (Pregnant women, Children and adolescents)

Primary outcomes:
measure: 1. Pneumothorax requiring chest tube reinsertion
timeFrame: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)
measure: 2. Pleural effusion requiring thoracocentesis
timeFrame: Pleural effusion 2 hours after chest tube removal between POD 0 and 30
measure: 3. Prolonged air leak > 5 days
timeFrame: Chest tube removal between POD 6 and 30
measure: 4. Re-admission or reoperation due to pleural complication
timeFrame: Up to 1 month after first operation
Secondary outcomes:
measure: 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS)
timeFrame: Up to 1 month after initial operation
measure: 2. Re-operation
timeFrame: Up to 1 month after initial operation
measure: 3. Length of drainage (days)
timeFrame: Up to 1 month after initial operation
measure: 4. Length of stay (days)
timeFrame: Up to 1 month after initial operation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern, Inselspital
Study officials:
affiliation: Chief, Department of General Thoracic Surgery, Inselspital
name: Patrick Dorn, PD
role: STUDY_DIRECTOR
References: