Actively Recruiting
Enhanced Perioperative Pulmonary Physiotherapy for Prevention of Pulmonary Complications After Laparoscopic Liver Surgery
Led by Oulu University Hospital · Updated on 2025-09-25
364
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
Sponsors
O
Oulu University Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of enhanced perioperative pulmonary physiotherapy on reducing postoperative pulmonary complications (PPCs) after laparoscopic liver surgery. PPCs include respiratory infections, atelectasis, pleural effusion, bronchospasm, aspiration pneumonitis, pneumothorax, exacerbations of chronic lung conditions, and respiratory failure, which can cause significant health issues and costs. This multicenter, randomized controlled trial aims to evaluate whether a short, easy-to-integrate physiotherapy program can lower PPC rates compared to standard perioperative care. The study compares two groups: one receiving enhanced pulmonary physiotherapy involving a preoperative session, an educational video, and daily exercises including deep breathing, coughing, pursed lip breathing, and positive expiratory pressure (PEP) therapy performed twice daily for 14 days (7 days before and 7 days after surgery). The control group receives standard perioperative breathing education based on Enhanced Recovery After Surgery (ERAS) protocols. Surgeons and researchers are blinded to group allocation to reduce bias. Participants will be assessed before surgery, at discharge, and 30 days postoperatively. Data collected include patient characteristics, surgical details, and postoperative outcomes such as PPC incidence within 14 days, length of hospital and ICU stays, antibiotic use, complications, mortality up to 90 days, and hospital costs. Compliance with the physiotherapy program will be monitored. The total participation duration covers preoperative preparation through 90 days of postoperative follow-up.
CONDITIONS
Brief Title
Prevention of Pulmonary Complications After Laparoscopic Liver Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who undergo elective, laparoscopic surgery of liver
- Patients who are able to provide informed written consent
- Patients capable of completing questionnaires at the time of consent
- Patients compliant in taking in preoperative pulmonary counseling and conducting the exercises
You will not qualify if you...
- Age less than 18 years
- Emergency surgery
- Planned open surgery
- Unwillingness to participate in the follow up assessment
- No informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) or remote appointment at a preoperative outpatient clinic 1 to 4 weeks prior to surgery
Duration - 7 days before surgery plus 7 days after surgery
Participants in the intervention group receive pulmonary physiotherapy education and training at home before and after surgery. This includes deep breathing, coughing, pursed lip breathing, and positive expiratory pressure therapy.
1 session preoperatively (in-person or via video) and home-based exercises twice daily for 14 days total
Duration - Day of surgery
Participants undergo elective laparoscopic liver surgery following standard perioperative care.
1 visit (in-person) for surgery
Duration - Up to 90 days after surgery
Participants are monitored for postoperative pulmonary complications and other outcomes including length of stay, ICU stay, antibiotic use, and complications up to 90 days after surgery.
Assessments at discharge and at 30 days postoperatively; additional monitoring up to 90 days
Trial Site Locations
Total: 5 locations
1
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
2
Oulu University Hospital
Oulu, Finland, 90100
Actively Recruiting
3
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
4
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
5
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
Research Team
M
MInna Nortunen, MD PhD
M
Marjo H Koskela, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here