Influence of daily preoperative step volume and preoperative incentive spirometry training on pulmonary complications after upper abdominal cancer surgery: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: C15; C16; C22; C24; C23; C25; C78.7; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach; Malignant neoplasm of liver and intrahepatic bile ducts

• Registration Number: DRKS00025102
• Lead Sponsor: niversitätsklinikum Augsburg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Patients undergoing curatively intended resection for malignant tumors of the esophagus, stomach, pancreas, liver, or biliary tract, or for liver metastases.

Exclusion Criteria

Non-consenting patients, underage patients, pregnant patients, patients undergoing emergency surgery, and patients participating in another intervention study that may have a potential impact on the endpoints of this study will be excluded from participation. Other exclusion criteria include pre-existing dementia, patients under legal guardianship, and patients who do not receive a resection. Patients with the following pre-existing conditions will be excluded from study:
- Pulmonary emphysema
- Severe COPD (GOLD III and IV)
- Bronchial asthma requiring therapy
- Severe heart failure NYHA III or NYHA IV

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of postoperative pulmonary complications

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints<br><br>- Thromboembolic complications<br>- Moderate or severe COVID-19 infection (NIH definition) during hospitalisation.<br>- Overall complication rate (Clavien-Dindo = II)<br>- Comprehensive Complication Index<br>- Mortality during stay and 30-day mortality<br>- Health status at 15 days, 30 days and 90 days postoperatively (measured by EQ-5D-5L)<br>- Quality of life 15 days, 30 days and 90 days postoperatively (collected by QLQ-C30)<br>- Length of hospital stay<br>- 5-year overall survival<br>- Incidence of pulmonary complications requiring drug, interventional or surgical therapy for treatment<br>- 30-day cumulative incidence of pulmonary complications / clinically relevant complications<br>- Length of possible ICU stay and duration of ventilation