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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025102

Enrollment

254

Registered

2022-02-04

Start date

2022-02-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15 C16 C22 C24 C23 C25 C78.7

Interventions

Group 1: Breathing exercises started preoperatively Group 2: Breathing exercises started postoperatively

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Rate of postoperative pulmonary complications	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026