Actively Recruiting
Effects of Prone Position and Voice Training After Major Abdominal Surgery
Led by Vastra Gotaland Region · Updated on 2024-05-30
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of adopting a prone position after major abdominal surgery, focusing on patients undergoing surgery for esophageal, gastric, or pancreas malignancies. The study involves a randomized clinical trial with over 200 patients to assess whether the prone position can improve ventilation and reduce risks such as pneumonia and thromboembolism. Additionally, a voice, speech, and singing protocol is included to explore further patient outcomes. Participants will be randomly assigned to one of two groups: one receiving the standard Enhanced Recovery After Surgery (ERAS) protocol alone, and the other receiving the ERAS protocol combined with scheduled periods in the prone position and voice training. The prone position is applied postoperatively during days 2 to 5 and also on day 7 after surgery. The study compares these approaches to observe differences in recovery and complications. Throughout the study, patients will be closely monitored for oxygen saturation and lung complications, with measurements taken on postoperative days 2 through 7. Additional assessments include lung volumes, patient experience ratings, length of hospital stay, and complications within 30 days. Researchers will also track vital signs, use of analgesics, blood samples for bleeding, inflammation, and infection markers. Follow-up continues up to one year to evaluate long-term postoperative outcomes and any treatment-related adverse events.
CONDITIONS
Brief Title
Effects of Prone Position After Major Abdominal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for abdominal surgery aiming to cure malignancy of the esophagus, stomach, or pancreas
You will not qualify if you...
- Unable to understand Swedish in writing or speaking
- Unable to perform a prone position before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days post-surgery
Participants undergo major abdominal surgery and receive either the standard ERAS protocol or ERAS with additional prone positioning and voice training during postoperative days 2 to 5 and day 7 to improve ventilation and reduce complications.
Daily visits on postoperative days 2 to 5 and 1 visit on postoperative day 7
Duration - Up to 1 year
Participants are monitored for lung and abdominal complications, lung volumes, hospital stay duration, and other health outcomes for up to 1 year after surgery.
Periodic visits through study completion up to 1 year
Trial Site Locations
Total: 1 location
1
Dept of Surgery
Gothenburg, Sweden
Actively Recruiting
Research Team
C
Cecilia Engstrom Mattisson, MD PhD
C
Cecilia Engstrom Mattisson, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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