Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection (CREATOR)

Rigshospitalet

Status: Completed

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

Treatments: Procedure: Standard chest drain placement; Procedure: Intraoperative air leak test; Procedure: Intraoperative chest drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05358158

H-21012837

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Drain-free group

Experimental group

Description:

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.

Treatment:

Procedure: Intraoperative chest drain removal

Procedure: Intraoperative air leak test

Chest drain group

Active Comparator group

Description:

Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.

Treatment:

Procedure: Standard chest drain placement

Procedure: Intraoperative air leak test