๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Suitable target areas in both lungs
* Age โฅ 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).
๐
What it tests
- Unilateral LVRS
- Bilateral LVRS
Rigshospitalet
Copenhagen, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.