ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively (TOTTI)

Rigshospitalet

Status: Unknown

Conditions: Decreased Lung Function; Delayed Discharge; Pain

Treatments: Procedure: Intraoperative chest tube removal; Procedure: Intraoperative sealing test; Procedure: Standard post-operative chest tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02829736

H-16028354

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Chest tube group

Active Comparator group

Description:

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

Treatment:

Procedure: Intraoperative sealing test

Procedure: Standard post-operative chest tube

No chest tube 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 tube removal

Procedure: Intraoperative sealing test