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Effects of Prone Position After Major Abdominal Surgery (EPOS)

Primary Purpose

Surgery, Complications, Postoperative, Lung Infection

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

prone position

About this trial

This is an interventional prevention trial for Surgery focused on measuring complications postoperative, lungcomplications, abdominal surgery, prone position

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

ERAS

+prone position

Arm Description

Ordinary ERAS treatment postoperatively without any prone position or voicetraining

Ordinary ERAS treatment adding the prone position and voicetraining in short intervals

Outcomes

Primary Outcome Measures

Oxygen saturation measurement postoperatively

Measurement during sitting position

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

Number of participants with treatment-related adverse events of postoperative lung and abdominal complications

Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

Secondary Outcome Measures

Number of participants with treatment-related diminished lung volumes

Spirometric measurements of diminished lung volumes

Number of days of Hospital care

Days of inhouse treatment

Number of participants needing intervention

Treament intervention like antibiotics or other medical or interventional treatment

Full Information

NCT ID

NCT05630443

First Posted

June 3, 2022

Last Updated

November 28, 2022

Sponsor

Vastra Gotaland Region

1. Study Identification

Unique Protocol Identification Number

NCT05630443

Brief Title

Effects of Prone Position After Major Abdominal Surgery

Acronym

EPOS

Official Title

Effects of Prone Position After Major Abdominal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgery, Complications, Postoperative, Lung Infection

Keywords

complications postoperative, lungcomplications, abdominal surgery, prone position

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

prospective randomized controlled study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ERAS

Arm Type

No Intervention

Arm Description

Ordinary ERAS treatment postoperatively without any prone position or voicetraining

Arm Title

+prone position

Arm Type

Active Comparator

Arm Description

Ordinary ERAS treatment adding the prone position and voicetraining in short intervals

Intervention Type

Procedure

Intervention Name(s)

prone position

Intervention Description

Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining

Primary Outcome Measure Information:

Title

Oxygen saturation measurement postoperatively

Description

Measurement during sitting position

Time Frame

an average of (POD) Postoperative day 2-7

Title

Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement

Description

Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis

Time Frame

through study completion, an average of 1 year

Title

Number of participants with treatment-related adverse events of postoperative lung and abdominal complications

Description

Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related diminished lung volumes

Description

Spirometric measurements of diminished lung volumes

Time Frame

through study completion, an average of 1 year

Title

Number of days of Hospital care

Description

Days of inhouse treatment

Time Frame

through study completion, an average of 1 year

Title

Number of participants needing intervention

Description

Treament intervention like antibiotics or other medical or interventional treatment

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cecilia Engstrom Mattisson, MD PhD

Phone

+46704970393

cecilia.engstrom.@surgery.gu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Cecilia Engstrom Mattisson, MD PhD

cecilia.engstrom.mattisson@vgregion.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecilia Engstrom Mattisson, MD PhD

Organizational Affiliation

Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Surgery

City

Göteborg

Country

Sweden

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The template is only shared with the two invesitagtors in this application.

Learn more about this trial

Effects of Prone Position After Major Abdominal Surgery

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