Lung Pathologies of Unclear EtiologyCTremovalNCT04670523
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries
A study testing Early postoperative day 0 (POD 0) chest tube removal. and Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1). in people with Lung Pathologies of Unclear Etiology, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Pathologies of Unclear Etiology
- What is being tested?
- Early postoperative day 0 (POD 0) chest tube removal. and Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
- Thoracoscopic pleural biopsy
- Signed consent
- Age of majority
Who cannot join
- Anatomical resection
- Empyema
- Pleural effusion
- Pleurodesis
- Vulnerable persons (Pregnant women, Children and adolescents)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern, Inselspital
Bern, 3013
Patrick Dorn, PD, 0041 31 632 37 45 ext. 0797696216, patrick.dorn@insel.ch
About this study
Official title: Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Lung Pathologies of Unclear Etiology
- Being tested
- 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early postoperative day 0 (POD 0) chest tube removal.Procedure or surgery
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).Procedure or surgery
Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
| Study group | Role | What they receive |
|---|---|---|
| Test group | Other | 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). Receives: Procedure: Early postoperative day 0 (POD 0) chest tube removal. |
| Control group | Other | In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day 1 (POD1). Receives: Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1). |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pneumothorax requiring chest tube reinsertion
Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 1 month after first operation
Secondary outcomes (4)
1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS)
Number of patients with cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) after operation
Measured: Up to 1 month after initial operation
2. Re-operation
Number of patients requiring a re-operation after initial operation
Measured: Up to 1 month after initial operation
3. Length of drainage (days)
Average of time with chest tube in site
Measured: Up to 1 month after initial operation
4. Length of stay (days)
Average of time in hospital
Measured: Up to 1 month after initial operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start6 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Pathologies of Unclear EtiologyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Dorn, PD, Study director, Chief, Department of General Thoracic Surgery, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670523
- Sponsor's protocol ID
- EROCT
- Acronym
- CTremoval
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be included in a manuscript and published in a journal to share the data and results of the study
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04670523
- Acronym / sponsor ID
- CTremoval / EROCT
- Conditions
- Lung Pathologies of Unclear Etiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group | Other | Procedure: Early postoperative day 0 (POD 0) chest tube removal.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). |
| Control group | Other | Procedure: Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day 1 (POD1). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
- Thoracoscopic pleural biopsy
- Signed consent
- Age of majority
Key exclusion criteria (5 listed)
- Anatomical resection
- Empyema
- Pleural effusion
- Pleurodesis
- Vulnerable persons (Pregnant women, Children and adolescents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Test group |
| 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). | Procedure or surgery | Control group |
Primary outcome
1. Pneumothorax requiring chest tube reinsertion
Time frame: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)
Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube
2. Pleural effusion requiring thoracocentesis
Time frame: Pleural effusion 2 hours after chest tube removal between POD 0 and 30
Number of patients with pleural effusion requiring thoracocentesis after removal of first chest tube
3. Prolonged air leak > 5 days
Time frame: Chest tube removal between POD 6 and 30
Number of patients with persisting air leak longer than 5 days
4. Re-admission or reoperation due to pleural complication
Time frame: Up to 1 month after first operation
Number of patients re-admitted to a hospital after first hospitalization
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Data will be included in a manuscript and published in a journal to share the data and results of the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Dorn, PD study director
Chief, Department of General Thoracic Surgery, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early postoperative day 0 (POD 0) chest tube removal. and Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1). in people with Lung Pathologies of Unclear Etiology, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Dorn, PD (0041 31 632 37 45 ext. 0797696216, patrick.dorn@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pneumothorax requiring chest tube reinsertion (time frame: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.