Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

NCT05358158 | Completed DMC

• 1 other identifier: H-21012837
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Neoplasms; Lung Surgery; Enhanced Recovery After Surgery; Fast-track Surgery; Pain; Opioid Use; Remission

Outcome Measures

Primary Outcomes (2)

• Acute Pain

  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

  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 Outcomes (9)

• Pneumothorax

  Up to postoperative 2 weeks

• Complications

  Up to postoperative day 30

• Chest drain reinsertion

  Up to postoperative day 30

• Length of stay

  Through post-operative discharge, an average of 2 days

• Time to fulfilled discharge criteria

  Through post-operative discharge, an average of 2 days

Study Arms (2)

Drain-free group

EXPERIMENTAL

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; Procedure: Intraoperative chest drain removal

Chest drain group

ACTIVE COMPARATOR

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; Procedure: Standard chest drain placement

Interventions

Intraoperative air leak test PROCEDURE

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.

Chest drain group; Drain-free group

Intraoperative chest drain removal PROCEDURE

Chest drain is removed intraoperatively.

Drain-free group

Standard chest drain placement PROCEDURE

Chest drain is left in pleura.

Chest drain group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Thomas Decker Christensen

Aarhus, Aarhus N, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (28)

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  PMID: 30233854 RESULT

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• Holbek BL, Huang L, Christensen TD, Bendixen M, Hansen HJ, Kehlet H, Petersen RH. Efficacy of avoiding chest drains after video-assisted thoracoscopic surgery wedge resection: protocol for a randomised controlled trial. BMJ Open. 2024 Feb 20;14(2):e080573. doi: 10.1136/bmjopen-2023-080573.

  PMID: 38382951 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• René H Petersen, MD, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Thomas D Christensen, MD, PhD

  Aarhus University Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of cardiothoracic surgery

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: May 4, 2022
• Primary Completion: March 17, 2024
• Study Completion: March 17, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The time when summary data are published.
• Access Criteria: Others who need the IPD and relevant information should ask the correspoding author of the publication

Locations

DK (2)