Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

Lung Pathologies of Unclear Etiology Clinical Trial

— CTremoval  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670523
• Other study ID #: EROCT
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: December 5, 2025

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Patrick Dorn, PD
• Phone: 0041 31 632 37 45
• Email: patrick.dorn[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: December 5, 2025
• Est. primary completion date: January 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Pathologies of Unclear Etiology

Intervention

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 airleak is persisting than chest tube removal will be performed according to the traditional 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).
Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).

Locations

Country	Name	City	State
Switzerland	University Hospital of Bern, Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	2. Re-operation	Number of patients requiring a re-operation after initial operation	Up to 1 month after initial operation
Secondary	3. Length of drainage (days)	Average of time with chest tube in site	Up to 1 month after initial operation
Secondary	4. Length of stay (days)	Average of time in hospital	Up to 1 month after initial operation