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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Decreased Lung Function; Delayed Discharge
• Intervention / Treatment: Procedure: Intraoperative sealing test; Procedure: Standard post-operative chest tube; Procedure: Intraoperative chest tube removal

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Bo L. Holbek, MD; Phone Number: +4535458429; Email: bo.laksafoss.holbek@regionh.dk
    • Contact: Henrik J. Hansen, MD; Phone Number: +4535450532; Email: henrik.jessen.hansen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest tube group; Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.	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.; Procedure: Standard post-operative chest tube; A regular chest tube is left in the pleura.
Experimental: No chest tube group; Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.	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.; Procedure: Intraoperative chest tube removal; Chest tube is removed intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Bo L. Holbek, MD, Rigshospitalet, Denmark; Study Director: Henrik J. Hansen, MD, Rigshospitalet, Denmark; Study Director: René H. Petersen, MD, Rigshospitalet, Denmark; Study Director: Henrik Kehlet, DMSc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: lung function; pain; lung metastasis; enhanced recovery after surgery; lung neoplasm; fast-track surgery; intraoperative chest tube removal; reasons for admission
• Other Study ID Numbers: H-16028354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO