Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

Not Applicable

Completed

• Conditions: Pain; Opioid Use; Lung Surgery; Fast-track Surgery; Enhanced Recovery After Surgery; Lung Neoplasms; Remission
• Interventions: Procedure: Intraoperative air leak test; Procedure: Intraoperative chest drain removal; Procedure: Standard chest drain placement

• Registration Number: NCT05358158
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Study Start: 2022-05-04
• Status Verified: 2024-03
• Primary Completion: 2024-03-17
• Study Completion: 2024-03-17
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain-free group	Intraoperative chest drain removal	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Drain-free group	Intraoperative air leak test	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Chest drain group	Intraoperative air leak test	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.
Chest drain group	Standard chest drain placement	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.

Primary Outcome Measures

Name	Time	Method
Acute Pain	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
Rescue analgesics	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 Outcome Measures

Name	Time	Method
Time to fulfilled discharge criteria	Through post-operative discharge, an average of 2 days	Days to meet discharge criteria but stay in hospital
Pneumothorax	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
Complications	Up to postoperative day 30	Surgical and medical complications including mortality
Quality of recovery after surgery	Up to postoperative day 1	Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery
Standard analgesics given	Up to postoperative 2 weeks	Number of patients who did not receive planned postoperative analgesics according to the standards at their institution
Persistent pain	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.
Length of stay	Through post-operative discharge, an average of 2 days	Days in hospital after index surgery
Readmission	Through post-operative admission, an average of 7 days	Number and reasons of readmissions
Chest drain reinsertion	Up to postoperative day 30	Number and reasons of chest drain reinsertion

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Thomas Decker Christensen; 🇩🇰 Aarhus, Aarhus N, Denmark