PREVIST TrialRecruiting

A Study of the Effect of Breathing Exercises and Daily Step Count Before Surgery on Pulmonary Complications Following Upper Abdominal Cancer Surgery

Gender
Women and men
Age
18 years and older
Trial type
Interventional
Line of therapy
First line
Phase

What is this trial about?

After surgery, particularly after major procedures in the abdominal or thoracic cavity—such as those performed to treat tumors in the upper abdomen—various pulmonary complications can occur. These complications impair recovery and can prolong the length of the hospital stay. The goal of the PREVIST study is to investigate whether targeted breathing exercises before surgery can reduce the risk of pulmonary complications and whether physical activity prior to surgery might influence the incidence of pulmonary or vascular complications. Patients aged 18 and older who are scheduled to undergo surgery to remove a malignant tumor in the upper abdomen (esophagus, stomach, liver, bile ducts, or pancreas) are eligible to participate in the study.

Trial flow

Requirements

Diagnosis: Malignant tumors of the oesophagus, stomach, pancreas, liver or bile ducts or liver metastases

Age: 18 years and older

Line of therapy: Erstlinie / bisher keine Therapie

Key inclusion criteria: Curative treatment approach with surgical resection

Allocation

Randomisierung

Treatment

Breathing exercises started preoperatively
Breathing exercises started postoperatively

Follow-up

60 months

Detailed description

Surgery in the upper abdomen, particularly to remove tumors, is a major procedure associated with an increased risk of postoperative pulmonary complications, such as pneumonia. Good physical preparation—particularly targeted breathing exercises and regular physical activity both before and after surgery—could help reduce these risks.

The goal of the PREVIST study is to investigate whether breathing exercises started before surgery, compared to those started only after surgery, can reduce the rate of pulmonary complications following upper abdominal cancer surgery. The study will also examine whether a higher daily step count before surgery likewise reduces the risk of complications. This is a randomized, interventional study. This means that patients are randomly assigned to one of two treatment groups. In one group, breathing exercises begin before surgery; in the other, they begin only afterward. The rate of pulmonary complications will then be compared between the two groups. The primary endpoint of the study is the number of pulmonary complications requiring treatment (e.g., with medication or surgery). In addition, the length of stay in the intensive care unit and the need for mechanical ventilation are being examined. Other health data (length of hospital stay, quality of life, and long-term survival) will be collected via questionnaires at 15, 30, and 90 days.

Adult patients aged 18 and older who have a malignant tumor in the esophagus, stomach, pancreas, liver, or bile ducts and who are scheduled to undergo curative surgery are eligible to participate in the study. Patients who require emergency surgery, as well as those with severe pre-existing lung or heart conditions, are excluded from participation. Patients with dementia or under legal guardianship, as well as pregnant women and minors, are also ineligible to participate in the study. Another exclusion criterion is concurrent participation in other studies. Patients with dementia or under legal guardianship, as well as pregnant women and minors, are not eligible to participate in the study. Another exclusion criterion is concurrent participation in other studies.

Facts

  1. What condition: malignant tumors in the upper abdomen (esophagus, stomach, liver, bile ducts, pancreas)
  2. Cancer characteristics: planned surgical removal with the intent to cure
  3. What the study investigates: the effect of preoperative breathing training and physical activity (number of steps) on postoperative complications
  4. Study objective: To reduce pulmonary and vascular complications after surgery
  5. Study duration: Follow-up for 90 days after surgery, with long-term follow-up for up to 5 years
  6. Study characteristics: randomized, two treatment groups, blinded evaluation of results

Trial sites

1 trial site in Germany is listed.

  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.