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Clinical Trials/NCT05630443
NCT05630443
Recruiting
Not Applicable

Effects of Prone Position After Major Abdominal Surgery

Vastra Gotaland Region1 site in 1 country200 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Vastra Gotaland Region
Enrollment
200
Locations
1
Primary Endpoint
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Engström-Mattisson

MD PhD Associated Professor

Vastra Gotaland Region

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis

Oxygen saturation measurement postoperatively

Time Frame: 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

Time Frame: through study completion, an average of 1 year

Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

Secondary Outcomes

  • Number of participants needing intervention(through study completion, an average of 1 year)
  • Number of participants with treatment-related diminished lung volumes(through study completion, an average of 1 year)
  • Number of days of Hospital care(through study completion, an average of 1 year)

Study Sites (1)

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