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NCT Number: NCT05630443

Effects of Prone Position After Major Abdominal Surgery

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.

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Key information

Conditions

Surgery Complications, Postoperative Lung Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Surgery

Gothenburg, Sweden

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prone position

Procedure

Ordinary ERAS treatment postoperatvely adding the prone position and voicetraining

Primary outcomes

  1. Oxygen saturation measurement postoperatively

    Time frame: an average of (POD) Postoperative day 2-7

    Measurement during sitting position

  2. 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

  3. 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

  1. Number of participants with treatment-related diminished lung volumes

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

    Spirometric measurements of diminished lung volumes

  2. Number of days of Hospital care

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

    Days of inhouse treatment

  3. Number of participants needing intervention

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

    Treament intervention like antibiotics or other medical or interventional treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Engstrom Mattisson, MD PhD

CONTACT

[email protected]

+46704970393

Cecilia Engstrom Mattisson, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Acronym: EPOS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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