Effects of Prone Position After Major Abdominal Surgery (EPOS)

Vastra Gotaland Region

Status: Enrolling

Conditions: Lung Infection; Surgery; Complications, Postoperative

Treatments: Procedure: prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT05630443

2021-06877-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ERAS

No Intervention group

Description:

Ordinary ERAS treatment postoperatively without any prone position or voicetraining

+prone position

Active Comparator group

Description:

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

Treatment:

Procedure: prone position