Effects of Prone Position After Major Abdominal Surgery

Surgery Clinical Trial

— EPOS  

Official title:

Effects of Prone Position After Major Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630443
• Other study ID #: 2021-06877-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Vastra Gotaland Region
• Contact: Cecilia Engstrom Mattisson, MD PhD
• Phone: +46704970393
• Email: cecilia.engstrom.[@]surgery.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complications, Postoperative
• Lung Infection
• Postoperative Complications
• Surgery

Intervention

Procedure:
• prone position
Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining

Locations

Country	Name	City	State
Sweden	Dept of Surgery	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation measurement postoperatively	Measurement during sitting position	an average of (POD) Postoperative day 2-7
Primary	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
Primary	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	Number of participants with treatment-related diminished lung volumes	Spirometric measurements of diminished lung volumes	through study completion, an average of 1 year
Secondary	Number of days of Hospital care	Days of inhouse treatment	through study completion, an average of 1 year
Secondary	Number of participants needing intervention	Treament intervention like antibiotics or other medical or interventional treatment	through study completion, an average of 1 year