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Completed

NCT Number: NCT05358158

Chest dRain rEmoval intrAoperatively afTer thoracOscopic 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.

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Key information

Conditions

Lung Neoplasms Enhanced Recovery After Surgery Fast-track Surgery Lung Diseases Lung Surgery Neoplasms Neoplasms by Site Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Remission Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Decker Christensen, Aarhus, Aarhus N, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Intraoperative chest drain removal

Procedure

Chest drain is removed intraoperatively.

Standard chest drain placement

Procedure

Chest drain is left in pleura.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Complications

    Time frame: Up to postoperative day 30

    Surgical and medical complications including mortality

  3. Chest drain reinsertion

    Time frame: Up to postoperative day 30

    Number and reasons of chest drain reinsertion

  4. Length of stay

    Time frame: Through post-operative discharge, an average of 2 days

    Days in hospital after index surgery

  5. 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

  6. Readmission

    Time frame: Through post-operative admission, an average of 7 days

    Number and reasons of readmissions

  7. 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

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: CREATOR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 3, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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