EPOS: Effects of Prone Position After Major Abdominal Surgery

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Recruiting

CT.gov ID

NCT05630443

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Complications, Postoperative Lung Infection	Procedure: prone position	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

prospective randomized controlled studyprospective randomized controlled study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effects of Prone Position After Major Abdominal Surgery

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Oxygen saturation measurement postoperatively [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 incl a CT scan for objective measurement [through study completion, an average of 1 year]
Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications [through study completion, an average of 1 year]
Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

Secondary Outcome Measures

Number of participants with treatment-related diminished lung volumes [through study completion, an average of 1 year]
Spirometric measurements of diminished lung volumes
Number of days of Hospital care [through study completion, an average of 1 year]
Days of inhouse treatment
Number of participants needing intervention [through study completion, an average of 1 year]
Treament intervention like antibiotics or other medical or interventional treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Surgery	Göteborg		Sweden

Sponsors and Collaborators

Vastra Gotaland Region

Investigators

Principal Investigator: Cecilia Engstrom Mattisson, MD PhD, Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cecilia Engström-Mattisson, MD PhD Associated Professor, Vastra Gotaland Region

ClinicalTrials.gov Identifier:

NCT05630443

Other Study ID Numbers:

2021-06877-01

First Posted:

Nov 29, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cecilia Engström-Mattisson, MD PhD Associated Professor, Vastra Gotaland Region

complications postoperative

lungcomplications

abdominal surgery

prone position

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Dec 1, 2022