Effects of Prone Position After Major Abdominal Surgery

Study Overview
=================
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.

Official Title
-----------------
Effects of Prone Position After Major Abdominal Surgery

Conditions
-----------------
Surgery, Complications, Postoperative, Lung Infection

Intervention / Treatment
-----------------
* Procedure: prone position


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: prospective randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ERAS<br>Ordinary ERAS treatment postoperatively without any prone position or voicetraining | |
| Active Comparator: +prone position<br>Ordinary ERAS treatment adding the prone position and voicetraining in short intervals | Procedure: prone position<br>* Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation measurement postoperatively | Measurement during sitting position | an average of (POD) Postoperative day 2-7 | 
| Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement | Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis | through study completion, an average of 1 year | 
| Number of participants with treatment-related adverse events of postoperative lung and abdominal complications | Pneumonia, Lung embolism, Empyema of the lung, pankreatitis | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related diminished lung volumes | Spirometric measurements of diminished lung volumes | through study completion, an average of 1 year | 
| Number of days of Hospital care | Days of inhouse treatment | through study completion, an average of 1 year | 
| Number of participants needing intervention | Treament intervention like antibiotics or other medical or interventional treatment | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complications postoperative, lungcomplications, abdominal surgery, prone position