Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03466593
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
Sponsor:
Göteborg University
Organization:
Study Overview
Official Title:
Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreMob
Brief Summary:
Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.
This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.
The study includes two substudies:
1. A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair \<6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.
This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.
The study includes two substudies:
1. A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair \<6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: