Effects of Prone Position After Major Abdominal Surgery
NCT ID: NCT05630443
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-10-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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ERAS
Ordinary ERAS treatment postoperatively without any prone position or voicetraining
No interventions assigned to this group
+prone position
Ordinary ERAS treatment adding the prone position and voicetraining in short intervals
prone position
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining
Interventions
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prone position
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\- preoperatively unable to perform a prone position
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Cecilia Engström-Mattisson
MD PhD Associated Professor
Principal Investigators
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Cecilia Engstrom Mattisson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden
Locations
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Dept of Surgery
Gothenburg, , Sweden
Countries
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Central Contacts
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Other Identifiers
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2021-06877-01
Identifier Type: -
Identifier Source: org_study_id
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