Overview
This study compares two surgical approaches for patients with severe Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema: unilateral (operating on one lung) versus bilateral (operating on both lungs) lung volume reduction surgery (LVRS).
Description
Lung volume reduction surgery removes damaged lung tissue to help patients breathe better, improve life quality, and increase exercise capacity. Historically, the hospital has performed this surgery unilaterally, while global standards often favor bilateral surgery to maximize lung function benefits.Existing data suggesting bilateral surgery is better is more than 20 years old, lacks randomization, and was gathered before modern surgical advances like keyhole surgery (VATS) and Enhanced Recovery After Surgery (ERAS) protocols. Additionally, bilateral surgery may carry higher risks of postoperative complications, longer hospital stays, and prolonged air leaks. This study aims to provide modern, unbiased evidence to determine which approach is superior.
Eligibility
Inclusion Criteria:
- Suitable target areas in both lungs
- Age ≥ 18 years.
- Speaks and understands Danish or English
- Informed consent obtained
- Usual inclusion criteria in LVRS:
Moderate to severe COPD with MRC score \> 2 \< 75 years old 17 \< BMI \> 30 FEV1 \> 20% and \< 45% of predicted RV \> 200% of predicted as a sign of relevant hyperinflation DLCO \> 20% of predicted The patient should be in ideal medical treatment and have completed rehabilitation A high-resolution CT \< 3 months old should follow the referral to MDT Absence of nodules suspicious of malignancy on CT scan Absence of significant comorbidity including severe cardiovascular disease LVEF normal Absence of pulmonary hypertension, TI-gradient \< 40 mmHg Absence of chronic or frequent lung infections Smoking abstinence six months prior to surgery Assessed as sufficiently physically fit to undergo surgery and rehabilitation
Exclusion Criteria:
- Dependent on wheelchair
- Living in nursery home
- Dependent on walker device
- Psychiatric disorder (anxiety, depression, schizophrenia)
- Simultaneous lung cancer surgery
- Massive adhesions during surgery assessed by the surgeon indicating problems postoperatively
- Increased risk of post-operative bleeding assessed perioperatively by the surgeon.
- Perioperative decision on not doing operation on the other side (medical, surgical or anaesthesiologic problems that favours a fast termination of the surgery, decided by the team in OR).
- Previous cardiothoracic surgery
- Increased bleeding risk (e.g., preoperative INR \>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
