Effects of Prone Position After Major Abdominal Surgery (EPOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Lung Infection; Complications, Postoperative
• Intervention / Treatment: Procedure: prone position

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia Engstrom Mattisson, MD PhD; Phone Number: +46704970393; Email: cecilia.engstrom.@surgery.gu.se
• Study Contact Backup: Name: Cecilia Engstrom Mattisson, MD PhD; Email: cecilia.engstrom.mattisson@vgregion.se

Study Locations

• Sweden
  • Göteborg, Sweden
    • Recruiting
    • Dept of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Cecilia Engstrom Mattisson, MD PhD, Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: prone position; abdominal surgery; complications postoperative; lungcomplications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2021-06877-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The template is only shared with the two invesitagtors in this application.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No