Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

Study Overview
=================
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.

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

Conditions
-----------------
Lung Pathologies of Unclear Etiology

Intervention / Treatment
-----------------
* Procedure: Early postoperative day 0 (POD 0) chest tube removal.
* Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test group<br>Test group: The patients of the study group are getting their chest tube removed according to the investigators' current airleak protocol (Flow <20 mL/ min on digital suction device) but already in the operating room immediately following wound closure (Postoperative day 0 (POD0)). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1). | Procedure: Early postoperative day 0 (POD 0) chest tube removal.<br>* 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 airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).<br>|
| Other: Control group<br>In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day 1 (POD1). | Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).<br>* Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Pneumothorax requiring chest tube reinsertion | Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube | Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30) | 
| 2. Pleural effusion requiring thoracocentesis | Number of patients with pleural effusion requiring thoracocentesis after removal of first chest tube | Pleural effusion 2 hours after chest tube removal between POD 0 and 30 | 
| 3. Prolonged air leak > 5 days | Number of patients with persisting air leak longer than 5 days | Chest tube removal between POD 6 and 30 | 
| 4. Re-admission or reoperation due to pleural complication | Number of patients re-admitted to a hospital after first hospitalization | Up to 1 month after first operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) | Number of patients with cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) after operation | Up to 1 month after initial operation | 
| 2. Re-operation | Number of patients requiring a re-operation after initial operation | Up to 1 month after initial operation | 
| 3. Length of drainage (days) | Average of time with chest tube in site | Up to 1 month after initial operation | 
| 4. Length of stay (days) | Average of time in hospital | Up to 1 month after initial operation |