Prevention of Pulmonary Complications After Laparoscopic Liver Surgery

NCT07192575 | Recruiting DMC

• 1 other identifier: 254/2023
• Study Type: interventional
• Target: 364
• Locations: 2 countries
• Sites: 5

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.

Conditions

Liver Surgery; Pulmonary Complications; Laparoscopic Liver Surgery

Keywords

liver surgery; prehabilitation; pulmonary complications; laparoscopic liver surgery

Outcome Measures

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

  Complications recorded until 14 days postoperatively

Secondary Outcomes (6)

• Length of stay

  90 days postoperatively

• Length of intensive care unit (ICU) stay

  90days post operatively

• Use of antibiotics postoperatively

  90 days postoperatively

• Postoperative complications

  90 days postoperatively

• Postoperative mortality

  90days postoperatively

Study Arms (2)

Perioperative pulmonary physiotherapy arm

ACTIVE COMPARATOR

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.

Behavioral: Perioperative Pulmonary Physiotherapy in Laparoscopic Liver Surgery

Control arm

NO INTERVENTION

The control group receives standard perioperative breathing education.

Interventions

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.

Also known as: Pulmonary prehabilitation, Preoprative physiotherapy, Prehabilitation in liver surgery

Perioperative pulmonary physiotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Age \<18 years
• Emergency surgery
• Planned open surgery
• Unwillingness to participate in the follow up assessment
• No informed consent

Sponsors & Collaborators

• Oulu University Hospital: lead
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Lund University Hospital: collaborator

Study Sites (5)

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, 90100, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Linköping University Hospital

Linköping, Sweden

NOT YET RECRUITING

Skåne University Hospital

Lund, Sweden

NOT YET RECRUITING

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

MInna Nortunen, MD PhD

CONTACT

+358453576898; minna.nortunen@pohde.fi

Marjo H Koskela, MD PhD

CONTACT

+35883152339; marjo.h.koskela@pohde.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD, consultant HPB surgeon

Model Details: A prospective, multicentre, single-blinded, randomized controlled trial will be conducted according to the study protocol at participating centers. A total of 364 patients scheduled for laparoscopic liver surgery will be randomized at 1:1 ratio into intervention arm or standard ERAS -based perioperative care arm. Block randomization will be used to ensure even distribution of patients with prior pulmonary conditions to both arms. Subgroup analyses will be planned for major/minor liver surgery, pulman

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 25, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FI (3); SE (2)