Effects of Prone Position After Major Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prone position.
- Who it may be relevant to
- Registry conditions: Surgery, Complications, Postoperative, Lung Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure prone position
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining
Primary outcome measures
- Oxygen saturation measurement postoperatively [Time frame: 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 [Time frame: through study completion, an average of 1 year]
- Number of participants with treatment-related adverse events of postoperative lung and abdominal complications [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
- Number of participants with treatment-related diminished lung volumes [Time frame: through study completion, an average of 1 year]
- Number of days of Hospital care [Time frame: through study completion, an average of 1 year]
- Number of participants needing intervention [Time frame: through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Dept of Surgery — Gothenburg
Identifiers
NCT: NCT05630443 · 2021-06877-01