Decreased Lung Function, Delayed Discharge, Pain
Conditions
Keywords
lung neoplasm, lung metastasis, enhanced recovery after surgery, fast-track surgery, intraoperative chest tube removal, pain, lung function, reasons for admission
Brief 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. 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.
Interventions
PROCEDUREIntraoperative sealing test
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.
PROCEDUREStandard post-operative chest tube
A regular chest tube is left in the pleura.
PROCEDUREIntraoperative chest tube removal
Chest tube is removed intraoperatively.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization occurs after ended surgery, thus masking allocation to the personnel and participant. After Randomization, there is no masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective thoracoscopic wedge resection * Speaks and understands Danish * FEV1 \>= 60% of expected
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on NRS | Through post-operative admission, an average of 1 day. | Differences in pain between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for post-operative admission | Through post-operative admission, an average of 1 day. | Daily evaluation of reasons for admission. |
| Lung function | Up to post-operative day 1. | FEV1 measured preoperatively and on post-operative day 1 at 8 am. |
| Reinsertion of chest tubes | Up to post-operative day 30. | Frequency of chest tube reinsertion. |
| Pneumothorax | Up to post-operative day 1. | Size and frequency of pneumothorax on x-ray after removal of chest tube |
| Complications | Up to post-operative day 30. | Surgical complications including mortality. |
Countries
Denmark
Contacts
STUDY_DIRECTORHenrik J. Hansen, MD
Rigshospitalet, Denmark
STUDY_DIRECTORRené H. Petersen, MD
Rigshospitalet, Denmark
STUDY_DIRECTORHenrik Kehlet, DMSc
Rigshospitalet, Denmark
PRINCIPAL_INVESTIGATORBo L. Holbek, MD
Rigshospitalet, Denmark
Outcome results
None listed