Actively Recruiting
Prevention of Pulmonary Complications After Laparoscopic Liver Surgery
Led by Oulu University Hospital · Updated on 2025-09-25
364
Participants Needed
5
Research Sites
160 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
* Background: Postoperative pulmonary complications (PPCs) are the most common complications after major upper abdominal surgery. PPCs include respiratory infections, severe atelectasis, pleural effusion, bronchospasm, aspiration pneumonitis, pneumothorax, exacerbation of chronic pulmonary condition, and respiratory failure. Although PPC rates are higher after open liver surgery, PPCs still occur in approximately 12-13% of patients undergoing laparoscopic liver surgery. Preoperative respiratory physiotherapy education reduces PPCs after open major abdominal surgery and after laparoscopic colorectal surgery. The aim of this study is to investigate the impact of enhanced perioperative pulmonary physiotherapy on the incidence of PPCs after laparoscopic liver surgery. * Methods: A prospective, multicentre, single-blinded, randomized controlled trial will be conducted according to the study protocol at participating centers. A total of 326 patients scheduled for laparoscopic liver surgery will be randomized at a 1:1 ratio into intervention group or standard Enhanced Recovery After Surgery (ERAS) -based perioperative education group. Surgeons/ researchers are blinded to the patient allocation. Patients in the intervention group receive preoperative breathing education in a single session and an educational video to guide pulmonary training at home. Pulmonary training lasts for 7 days prior to surgery and for 7 days postoperatively. The training includes deep breathing, and coughing, pursed lip breathing and positive expiratory pressure (PEP) therapy. Patients receive instructions for conducting exercises along with an individual risk assessment at a preoperative ambulatory visit. The exercise session (10min) is to be performed two times daily for total of 14 days. The control group receives standard perioperative breathing education. Primary outcome is the rate of postoperative pulmonary complications within 14 days of operation. Secondary outcomes include 90-day mortality, Clavien-Dindo classified complications, length of hospital stay, intensive care unit (ICU) stay, and hospital costs. * Discussion: Little effort is currently put into preventing pulmonary complications after surgery, although PPCs aggravate considerable morbidity and costs to health care system. ERAS Society protocols concentrate mainly on optimizing postoperative recovery. Laparoscopic techniques as such and frequent manipulation of the diaphragm during liver surgery provoke PPCs at a considerable rate. Aim of the study is to present a short-and-easy perioperative pulmonary physiotherapy initiative and evaluate its impact on PPC rate and PPCs ramifications, including direct costs, after laparoscopic liver surgery.
CONDITIONS
Official 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
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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
CONTACT
M
Marjo H Koskela, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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