CREATOR: Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection
Study Details
Study Description
Brief Summary
Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease.
Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Drain-free group Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. |
Procedure: Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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: Intraoperative chest drain removal
Chest drain is removed intraoperatively.
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| Active Comparator: Chest drain group Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube. |
Procedure: Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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: Standard chest drain placement
Chest drain is left in pleura.
|
Outcome Measures
Primary Outcome Measures
- Acute Pain [Up to postoperative day 1]
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m
- Rescue analgesics [Up to postoperative day 1]
The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry
Secondary Outcome Measures
- Pneumothorax [Up to postoperative 2 weeks]
Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both
- Complications [Up to postoperative day 30]
Surgical and medical complications including mortality
- Chest drain reinsertion [Up to postoperative day 30]
Number and reasons of chest drain reinsertion
- Length of stay [Through post-operative discharge, an average of 2 days]
Days in hospital after index surgery
- Time to fulfilled discharge criteria [Through post-operative discharge, an average of 2 days]
Days to meet discharge criteria but stay in hospital
- Readmission [Through post-operative admission, an average of 7 days]
Number and reasons of readmissions
- Quality of recovery after surgery [Up to postoperative day 1]
Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery
- Standard analgesics given [Up to postoperative 2 weeks]
Number of patients who did not receive planned postoperative analgesics according to the standards at their institution
- Persistent pain [Up to postoperative day 6]
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years.
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Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
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first second forced expiratory volume ≥60% of expected.
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No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
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Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
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Able and willing to give informed consent.
Exclusion Criteria:
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Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
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Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
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Air leak during intraoperative air leak test.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rigshospitalet, Denmark
- Aarhus University Hospital
Investigators
- Study Chair: René H Petersen, MD, PhD, Rigshospitalet, Denmark
- Study Director: Thomas D Christensen, MD, PhD, Aarhus University Hospital
- Principal Investigator: Bo L Holbek, MD, PhD, Rigshospitalet, Denmark
- Principal Investigator: Morten Bendixen, MD, PhD, Aarhus University Hospital
- Principal Investigator: Jonas J Rasmussen, MD, Aarhus University Hospital
- Principal Investigator: Henrik Kehlet, MD, PhD, Rigshospitalet, Denmark
- Principal Investigator: Henrik J Hansen, MD, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-21012837