Prevention of Pulmonary Complications After Laparoscopic Liver Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOulu University Hospital

About this trial

* 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years

Emergency surgery

Planned open surgery

Unwillingness to participate in the follow up assessment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perioperative Pulmonary Physiotherapy in Laparoscopic Liver Surgery

    Behavioral

    The intervention includes pulmonary physiotherapy training 7 days prior to surgery and 7 days postoperatively. Patients receive physiotherapy education in a single session preoperatively or via an educational video, to guide pulmonary training at home. The pulmonary 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 a total of 14 days.

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: Perioperative pulmonary physiotherapy armActive comparator 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of postoperative pulmonary complications (PPCs) within 14 days of operation

PPC is diagnosed when four or more of the following criteria were present: * Chest radiograph report of collapse/consolidation/ clinically relevant effusion/ edema * Raised maximum oral temperature \> 38o C on more than one consecutive postoperative day * Pulse oximetry oxygen saturation (SpO2) \< 90% on more than one consecutive postoperative day * Production of yellow or green sputum different to preoperative assessment * Presence of infection on sputum culture report * An otherwise unexplained white cell count greater than 11 x 109/l or prescription of an antibiotic specific for respiratory infection * New abnormal breath sounds on auscultation different to preoperative assessment * Physician's diagnosis of postoperative pulmonary complication * Presence of pneumonia, bronchitis or clinically relevant effusion/edema on computed chest tomography * Presence of pulmonary embolism (PE) on computed chest tomography * Exacerbation of chronic pulmonary condition (defined as a need to

Time frame
Complications recorded until 14 days postoperatively

Secondary outcomes

1

Length of stay

Length of postoperative hospital stay (days)

Time frame
90 days postoperatively
2

Length of intensive care unit (ICU) stay

Length of intensive care unit (ICU) stay (days)

Time frame
90days post operatively
3

Use of antibiotics postoperatively

Use of antibiotics postoperatively, duration, indication, amount and used drug

Time frame
90 days postoperatively
4

Postoperative complications

Postoperative complications according to Clavien-Dindo

Time frame
90 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oulu University Hospital

Lead sponsor

Tampere University Hospital

Collaborator

Kuopio University Hospital

Collaborator

University Hospital, Linkoeping

Collaborator

Lund University Hospital

Collaborator