Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection

Conditions
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Fast-track Surgery, Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery, Pain, Opioid Use, Remission

Intervention / Treatment
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* Procedure: Intraoperative air leak test
* Procedure: Intraoperative chest drain removal
* Procedure: Standard chest drain placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules. first second forced expiratory volume ≥60% of expected. 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). Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy. Able and willing to give informed consent. Exclusion Criteria: 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). Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing). Air leak during intraoperative air leak test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drain-free group<br>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<br>* 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.<br>Procedure: Intraoperative chest drain removal<br>* Chest drain is removed intraoperatively.<br>|
| Active Comparator: Chest drain group<br>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<br>* 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.<br>Procedure: Standard chest drain placement<br>* Chest drain is left in pleura.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Pain | 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 | Up to postoperative day 1 | 
| Rescue analgesics | 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 | Up to postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumothorax | 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 | Up to postoperative 2 weeks | 
| Complications | Surgical and medical complications including mortality | Up to postoperative day 30 | 
| Chest drain reinsertion | Number and reasons of chest drain reinsertion | Up to postoperative day 30 | 
| Length of stay | Days in hospital after index surgery | Through post-operative discharge, an average of 2 days | 
| Time to fulfilled discharge criteria | Days to meet discharge criteria but stay in hospital | Through post-operative discharge, an average of 2 days | 
| Readmission | Number and reasons of readmissions | Through post-operative admission, an average of 7 days | 
| Quality of recovery after surgery | Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery | Up to postoperative day 1 | 
| Standard analgesics given | Number of patients who did not receive planned postoperative analgesics according to the standards at their institution | Up to postoperative 2 weeks | 
| Persistent pain | Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6. | Up to postoperative day 6 |