Pancreas Cancer
Conditions
Keywords
Prehabilitation, Recovery, Complications
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.
Interventions
OTHERPrehabilitation
Prehabilitation concerning eating, smoking, drinking and physical activity
OTHERRoutine care
Preoperative information
OTHERExtra early mobilization
Mobilization the day of surgery
Mobilization the day after surgery
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1. A prospective cohort compared to historical controls 2. A randomized, controlled, intervention study.
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Whole study period from inclusion to one year after surgery | Standardized complications according to register |
| PaO2 | The day before surgery to the first day after surgery | Arterial oxygen pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC-module for fatigue | Whole study period from inclusion to one year after surgery | Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life |
| The Postoperative Recovery Profile | Whole study period from inclusion to one year after surgery | Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem |
| EORTC-module generic | Whole study period from inclusion to one year after surgery | Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life |
| Spirometry | From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation | Vital capacity |
| Lenght of stay | From the day before surgery to discharge from the hospital (app 7-14 days) | Length of stay at the hospital |
| Pancreatic cancer disease impact (PACADI) score | Whole study period from inclusion to one year after surgery | Disease specific questionnaire, 8 statements rated on a visual analogue scale from 0 (no problem) to 10 (worst imaginable problem). Sum score are used for analysis (Range 0-80) |
| EORTC-module specific for pancreas cancer | Whole study period from inclusion to one year after surgery | Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life |
Countries
Sweden
Outcome results
None listed