Effects of Prone Position After Major Abdominal Surgery

Not Applicable

Recruiting

• Conditions: Surgery; Complications, Postoperative; Lung Infection
• Interventions: Procedure: prone position

• Registration Number: NCT05630443
• Lead Sponsor: Vastra Gotaland Region

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.

Study Timeline

• Study First Submitted: 2022-06-03
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-11-27
• Study First Posted: 2022-11-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
+prone position	prone position	Ordinary ERAS treatment adding the prone position and voicetraining in short intervals

Primary Outcome Measures

Name	Time	Method
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
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	through study completion, an average of 1 year	Pneumonia, Lung embolism, Empyema of the lung, pankreatitis

Secondary Outcome Measures

Name	Time	Method
Number of participants needing intervention	through study completion, an average of 1 year	Treament intervention like antibiotics or other medical or interventional treatment
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

Trial Locations

Locations (1)

Dept of Surgery; 🇸🇪 Göteborg, Sweden