Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection (CREATOR)

March 19, 2024 updated by: Lin Huang, Rigshospitalet, Denmark

Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Thomas Decker Christensen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drain-free group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Procedure: Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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 drain removal
Chest drain is removed intraoperatively.
Active Comparator: Chest drain group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.
Procedure: Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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 chest drain placement
Chest drain is left in pleura.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Pain
Time Frame: Up to postoperative day 1
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m
Up to postoperative day 1
Rescue analgesics
Time Frame: Up to postoperative day 1
The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry
Up to postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumothorax
Time Frame: Up to postoperative 2 weeks
Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both
Up to postoperative 2 weeks
Complications
Time Frame: Up to postoperative day 30
Surgical and medical complications including mortality
Up to postoperative day 30
Chest drain reinsertion
Time Frame: Up to postoperative day 30
Number and reasons of chest drain reinsertion
Up to postoperative day 30
Length of stay
Time Frame: Through post-operative discharge, an average of 2 days
Days in hospital after index surgery
Through post-operative discharge, an average of 2 days
Time to fulfilled discharge criteria
Time Frame: Through post-operative discharge, an average of 2 days
Days to meet discharge criteria but stay in hospital
Through post-operative discharge, an average of 2 days
Readmission
Time Frame: Through post-operative admission, an average of 7 days
Number and reasons of readmissions
Through post-operative admission, an average of 7 days
Quality of recovery after surgery
Time Frame: Up to postoperative day 1
Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery
Up to postoperative day 1
Standard analgesics given
Time Frame: Up to postoperative 2 weeks
Number of patients who did not receive planned postoperative analgesics according to the standards at their institution
Up to postoperative 2 weeks
Persistent pain
Time Frame: Up to postoperative day 6
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.
Up to postoperative day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Aarhus University Hospital

Investigators

  • Study Chair: René H Petersen, MD, PhD, Rigshospitalet, Denmark
  • Study Director: Thomas D Christensen, MD, PhD, Aarhus University Hospital
  • Principal Investigator: Bo L Holbek, MD, PhD, Rigshospitalet, Denmark
  • Principal Investigator: Morten Bendixen, MD, PhD, Aarhus University Hospital
  • Principal Investigator: Jonas J Rasmussen, MD, Aarhus University Hospital
  • Principal Investigator: Henrik Kehlet, MD, PhD, Rigshospitalet, Denmark
  • Principal Investigator: Henrik J Hansen, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Actual)

March 17, 2024

Study Completion (Actual)

March 17, 2024

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21012837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication are planned to share to other researchers if they connect with the corresponding author of the publication.

IPD Sharing Time Frame

The time when summary data are published.

IPD Sharing Access Criteria

Others who need the IPD and relevant information should ask the correspoding author of the publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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