Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.

Study Overview
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Brief Summary
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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.

Official Title
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Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Other: Prehabilitation
* Other: Routine care
* Other: Extra early mobilization
* Other: Standard mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo pancreatic surgery Exclusion Criteria in substudy b: Preoperative injury or disease making it impossible to perform the intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective cohort compared to historical controls A randomized, controlled, intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective cohort-prehabilitation<br>A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol. | Other: Prehabilitation<br>* Prehabilitation concerning eating, smoking, drinking and physical activity<br>|
| Active Comparator: Retrospective cohort<br>Routine care before the prehabilitation program was introduced | Other: Routine care<br>* Preoperative information<br>|
| Experimental: Extra early mobilization<br>Mobilization the day of surgery | Other: Extra early mobilization<br>* Mobilization the day of surgery<br>|
| Active Comparator: Traditional mobilization<br>Routine care with mobilization the day after surgery | Other: Standard mobilization<br>* Mobilization the day after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Standardized complications according to register | Whole study period from inclusion to one year after surgery | 
| PaO2 | Arterial oxygen pressure | The day before surgery to the first day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC-module generic | Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life | Whole study period from inclusion to one year after surgery | 
| EORTC-module specific for pancreas cancer | Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life | Whole study period from inclusion to one year after surgery | 
| EORTC-module for fatigue | Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life | Whole study period from inclusion to one year after surgery | 
| The Postoperative Recovery Profile | Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem | Whole study period from inclusion to one year after surgery | 
| Pancreatic cancer disease impact (PACADI) score | 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) | Whole study period from inclusion to one year after surgery | 
| Spirometry | Vital capacity | From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation | 
| Lenght of stay | Length of stay at the hospital | From the day before surgery to discharge from the hospital (app 7-14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Recovery, Complications