PainTOTTINCT02829736
ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively
A study testing Intraoperative sealing test, Standard post-operative chest tube and Intraoperative chest tube removal in people with Pain and Decreased Lung Function, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Decreased Lung Function, Delayed Discharge
- What is being tested?
- Intraoperative sealing test, Standard post-operative chest tube and Intraoperative chest tube removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective thoracoscopic wedge resection
- Speaks and understands Danish
- FEV1 >= 60% of expected
Who cannot join
- Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
- Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
- Air leak on intraoperative sealing test
- Patients previously included in study
- Planned intraoperative frozen section with possible lobectomy
- Previously included in current study
- Planned frozen section diagnostics
- Previous ipsilateral anatomic lung resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study
Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.
Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
- Conditions
- Pain, Decreased Lung Function, Delayed Discharge
- Being tested
- Intraoperative sealing test, Standard post-operative chest tube, Intraoperative chest tube removal
- Keywords
- lung neoplasm, lung metastasis, enhanced recovery after surgery, fast-track surgery, intraoperative chest tube removal, pain, lung function, reasons for admission
- Medical subject headings
- Pain, Respiratory Insufficiency, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative sealing testProcedure or surgery
A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
Standard post-operative chest tubeProcedure or surgery
A regular chest tube is left in the pleura.
Intraoperative chest tube removalProcedure or surgery
Chest tube is removed intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Chest tube group | Active comparator | Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube. Receives: Procedure: Intraoperative sealing test; Procedure: Standard post-operative chest tube |
| No chest tube group | Experimental | Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. Receives: Procedure: Intraoperative sealing test; Procedure: Intraoperative chest tube removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on NRS
Differences in pain between the two groups.
Measured: Through post-operative admission, an average of 1 day.
Secondary outcomes (5)
Reasons for post-operative admission
Daily evaluation of reasons for admission.
Measured: Through post-operative admission, an average of 1 day.
Lung function
FEV1 measured preoperatively and on post-operative day 1 at 8 am.
Measured: Up to post-operative day 1.
Reinsertion of chest tubes
Frequency of chest tube reinsertion.
Measured: Up to post-operative day 30.
Pneumothorax
Size and frequency of pneumothorax on x-ray after removal of chest tube
Measured: Up to post-operative day 1.
Complications
Surgical complications including mortality.
Measured: Up to post-operative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionAug 2017
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Laksáfoss Holbek, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik J. Hansen, MD, Study director, Copenhagen University Hospital, RigshospitaletRené H. Petersen, MD, Study director, Copenhagen University Hospital, RigshospitaletHenrik Kehlet, DMSc, Study director, Copenhagen University Hospital, RigshospitaletBo L. Holbek, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829736
- Sponsor's protocol ID
- H-16028354
- Acronym
- TOTTI
- Status last verified
- Oct 2017
- First submitted
- 8 Jul 2016
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02829736
- Acronym / sponsor ID
- TOTTI / H-16028354
- Conditions
- Pain, Decreased Lung Function, Delayed Discharge
- Keywords
- lung neoplasm, lung metastasis, enhanced recovery after surgery, fast-track surgery, intraoperative chest tube removal, pain, lung function, reasons for admission
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.
Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest tube group | Active comparator | Procedure: Intraoperative sealing test, Procedure: Standard post-operative chest tubeParticipants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube. |
| No chest tube group | Experimental | Procedure: Intraoperative sealing test, Procedure: Intraoperative chest tube removalParticipants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective thoracoscopic wedge resection
- Speaks and understands Danish
- FEV1 >= 60% of expected
Key exclusion criteria (8 listed)
- Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
- Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
- Air leak on intraoperative sealing test
- Patients previously included in study
- Planned intraoperative frozen section with possible lobectomy
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 |
|---|---|---|
| Intraoperative sealing testA standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test. | Procedure or surgery | Chest tube group, No chest tube group |
| Standard post-operative chest tubeA regular chest tube is left in the pleura. | Procedure or surgery | Chest tube group |
| Intraoperative chest tube removalChest tube is removed intraoperatively. | Procedure or surgery | No chest tube group |
Primary outcome
Pain on NRS
Time frame: Through post-operative admission, an average of 1 day.
Differences in pain between the two groups.
5 secondary outcomes
Reasons for post-operative admission
Time frame: Through post-operative admission, an average of 1 day.
Lung function
Time frame: Up to post-operative day 1.
Reinsertion of chest tubes
Time frame: Up to post-operative day 30.
Pneumothorax
Time frame: Up to post-operative day 1.
Complications
Time frame: Up to post-operative day 30.
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Henrik J. Hansen, MD study director
Copenhagen University Hospital, Rigshospitalet
René H. Petersen, MD study director
Copenhagen University Hospital, Rigshospitalet
Henrik Kehlet, DMSc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative sealing test, Standard post-operative chest tube and Intraoperative chest tube removal in people with Pain and Decreased Lung Function, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Jul 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 Denmark. 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on NRS (time frame: Through post-operative admission, an average of 1 day.). 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 1 Jul 2026.