ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

Not Applicable

• Conditions: Delayed Discharge; Pain; Decreased Lung Function
• Interventions: Procedure: Intraoperative sealing test; Procedure: Intraoperative chest tube removal; Procedure: Standard post-operative chest tube

• Registration Number: NCT02829736
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-07
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No chest tube group	Intraoperative chest tube removal	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Chest tube group	Intraoperative sealing test	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.
Chest tube group	Standard post-operative chest tube	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.
No chest tube group	Intraoperative sealing test	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.

Primary Outcome Measures

Name	Time	Method
Pain	Through post-operative admission, an average of 1 day.	Average pain expressed as area under the curve from a numeric rank score at 1, 3, 6 and 9 hours after surgery as well as daily at 8 am and 8 pm from post-operative day 1 until discharge.

Secondary Outcome Measures

Name	Time	Method
Reasons for post-operative admission	Through post-operative admission, an average of 1 day.	Daily evaluation of reasons for admission.
Pneumothorax	Up to post-operative day 1.	Size and frequency of pneumothorax on x-ray after removal of chest tube
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.
Complications	Up to post-operative day 30.	Surgical complications including mortality.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark