NCT07192575 Prevention of Pulmonary Complications After Laparoscopic Liver Surgery
| NCT ID | NCT07192575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Liver Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 364 participants |
| Start Date | 2024-09-15 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 364 participants in total. It began in 2024-09-15 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* 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.
Eligibility Criteria
Inclusion Criteria * 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 Exclusion Criteria: * Age \<18 years * Emergency surgery * Planned open surgery * Unwillingness to participate in the follow up assessment * No informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07192575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07192575 currently recruiting?
Yes, NCT07192575 is actively recruiting participants. Contact the research team at minna.nortunen@pohde.fi for enrollment information.
Where is the NCT07192575 trial being conducted?
This trial is being conducted at Kuopio, Finland, Oulu, Finland, Tampere, Finland, Linköping, Sweden and 1 additional location.
Who is sponsoring the NCT07192575 clinical trial?
NCT07192575 is sponsored by Oulu University Hospital. The trial plans to enroll 364 participants.