Enhanced Perioperative Pulmonary Physiotherapy for Prevention of Pulmonary Complications After Laparoscopic Liver Surgery

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Sweden
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Skåne University Hospital
NOT_YET_RECRUITING
Lund
Contact Information
Primary
MInna Nortunen, MD PhD
minna.nortunen@pohde.fi
+358453576898
Backup
Marjo H Koskela, MD PhD
marjo.h.koskela@pohde.fi
+35883152339
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 364
Treatments
Active_comparator: Perioperative pulmonary physiotherapy arm
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. The exercise session (10min) is to be performed two times daily for total of 14 days.
No_intervention: Control arm
The control group receives standard perioperative breathing education.
Sponsors
Collaborators: Tampere University Hospital, University Hospital, Linkoeping, Lund University Hospital, Kuopio University Hospital
Leads: Oulu University Hospital

This content was sourced from clinicaltrials.gov