Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

Rigshospitalet, Denmark94 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Neoplasms Lung Surgery Enhanced Recovery After Surgery Fast-track Surgery Pain

Interventions

Intraoperative air leak testPROCEDURE

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 removalPROCEDURE

Chest drain is removed intraoperatively.

Standard chest drain placementPROCEDURE

Chest drain is left in pleura.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Thomas Decker Christensen

Aarhus, Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Up to postoperative day 1

Secondary Outcomes

Pneumothorax

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

Time frame: Up to postoperative 2 weeks

Complications

Surgical and medical complications including mortality

Time frame: Up to postoperative day 30

Chest drain reinsertion

Number and reasons of chest drain reinsertion

Time frame: Up to postoperative day 30

Length of stay

Days in hospital after index surgery

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

Time to fulfilled discharge criteria

Days to meet discharge criteria but stay in hospital

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

Readmission

Number and reasons of readmissions

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

Quality of recovery after surgery

Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery

Time frame: Up to postoperative day 1

Standard analgesics given

Number of patients who did not receive planned postoperative analgesics according to the standards at their institution

Time frame: Up to postoperative 2 weeks

Persistent pain

Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.

Time frame: Up to postoperative day 6