Complications, Postoperative, Lung Infection, Surgery
Conditions
Keywords
complications postoperative, lungcomplications, abdominal surgery, prone position
Brief summary
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
Detailed description
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol. The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery. They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7. The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism. Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure. Exclusion criteria Patients unable to understand Swedish in writing or speaking, preoperatively unable to perform a prone position. The participation is voluntary and demands an inform consent from the patient operated upon. The primary outcome is oxygen saturation and lung complications after surgery. The secondary outcome is measurement of lung volumes, patient experience (7th graded Lickert scale), days of hospital care, 30 days complications etc. Further investigations are perioperative properties as BMI, other forms of surgery, etc., and continues measurement of blood pressure, respiration frequency, heartrate, tubes and drainages, postoperative analgesic, blood samples with signs of bleeding, inflammation, infection.
Interventions
PROCEDUREprone position
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
prospective randomized controlled study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients eligable for abdominal surgery aim to cure with: Inclusion Criteria: \- malignancy of the esophagus, gastric- or pancreas
Exclusion criteria
-.not able to understand Swedish in writing or speaking \- preoperatively unable to perform a prone position
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation measurement postoperatively | an average of (POD) Postoperative day 2-7 | Measurement during sitting position |
| Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement | through study completion, an average of 1 year | Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis |
| Number of participants with treatment-related adverse events of postoperative lung and abdominal complications | through study completion, an average of 1 year | Pneumonia, Lung embolism, Empyema of the lung, pankreatitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related diminished lung volumes | through study completion, an average of 1 year | Spirometric measurements of diminished lung volumes |
| Number of days of Hospital care | through study completion, an average of 1 year | Days of inhouse treatment |
| Number of participants needing intervention | through study completion, an average of 1 year | Treament intervention like antibiotics or other medical or interventional treatment |
Countries
Sweden
Contacts
Primary ContactCecilia Engstrom Mattisson, MD PhD
Backup ContactCecilia Engstrom Mattisson, MD PhD
Outcome results
None listed