Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- PaO2
Study Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled to undergo pancreatic surgery
Exclusion Criteria
- •in substudy b:
- •Preoperative injury or disease making it impossible to perform the intervention
Arms & Interventions
Prospective cohort-prehabilitation
A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.
Intervention: Prehabilitation (Other)
Retrospective cohort
Routine care before the prehabilitation program was introduced
Intervention: Routine care (Other)
Extra early mobilization
Mobilization the day of surgery
Intervention: Extra early mobilization (Other)
Traditional mobilization
Routine care with mobilization the day after surgery
Intervention: Standard mobilization (Other)
Outcomes
Primary Outcomes
PaO2
Time Frame: The day before surgery to the first day after surgery
Arterial oxygen pressure
Postoperative complications
Time Frame: Whole study period from inclusion to one year after surgery
Standardized complications according to register
Secondary Outcomes
- EORTC-module generic(Whole study period from inclusion to one year after surgery)
- EORTC-module specific for pancreas cancer(Whole study period from inclusion to one year after surgery)
- EORTC-module for fatigue(Whole study period from inclusion to one year after surgery)
- The Postoperative Recovery Profile(Whole study period from inclusion to one year after surgery)
- Spirometry(From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation)
- Lenght of stay(From the day before surgery to discharge from the hospital (app 7-14 days))
- Pancreatic cancer disease impact (PACADI) score(Whole study period from inclusion to one year after surgery)