Clinical trial NCT05630443: Effects of Prone Position After Major Abdominal Surgery
Official title: Effects of Prone Position After Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Complications, Postoperative
Lung Infection
Keywords: complications postoperative
lungcomplications
abdominal surgery
prone position
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-11-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective randomized controlled study
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Oxygen saturation measurement postoperatively
timeFrame: an average of (POD) Postoperative day 2-7
measure: Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
timeFrame: through study completion, an average of 1 year
measure: Number of participants with treatment-related adverse events of postoperative lung and abdominal complications
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with treatment-related diminished lung volumes
timeFrame: through study completion, an average of 1 year
measure: Number of days of Hospital care
timeFrame: through study completion, an average of 1 year
measure: Number of participants needing intervention
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Dept of Surgery
Study officials:
affiliation: Dept of Surgery, Sahlgrenska University Hospital, Gothenburg University, Sweden
name: Cecilia Engstrom Mattisson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: