ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

Pain Clinical Trial

— TOTTI  

Official title:

Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829736
• Other study ID #: H-16028354
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2016
• Last updated: October 31, 2017
• Start date: September 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2017
• Source: Rigshospitalet, Denmark
• Contact: Bo L. Holbek, MD
• Phone: +4535458429
• Email: bo.laksafoss.holbek[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decreased Lung Function
• Delayed Discharge
• Pain

Intervention

Procedure:
• Intraoperative sealing test
A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are 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.
• Standard post-operative chest tube
A regular chest tube is left in the pleura.
• Intraoperative chest tube removal
Chest tube is removed intraoperatively.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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.	Through post-operative admission, an average of 1 day.
Secondary	Reasons for post-operative admission	Daily evaluation of reasons for admission.	Through post-operative admission, an average of 1 day.
Secondary	Lung function	FEV1 measured preoperatively and on post-operative day 1 at 8 am.	Up to post-operative day 1.
Secondary	Reinsertion of chest tubes	Frequency of chest tube reinsertion.	Up to post-operative day 30.
Secondary	Pneumothorax	Size and frequency of pneumothorax on x-ray after removal of chest tube	Up to post-operative day 1.
Secondary	Complications	Surgical complications including mortality.	Up to post-operative day 30.