Clinical trial NCT03466593: Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
Official title: Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Keywords: Prehabilitation
Recovery
Complications
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 245
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. A prospective cohort compared to historical controls
2. A randomized, controlled, intervention study.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

* Preoperative injury or disease making it impossible to perform the intervention

Primary outcomes:
measure: Postoperative complications
timeFrame: Whole study period from inclusion to one year after surgery
measure: PaO2
timeFrame: The day before surgery to the first day after surgery
Secondary outcomes:
measure: EORTC-module generic
timeFrame: Whole study period from inclusion to one year after surgery
measure: EORTC-module specific for pancreas cancer
timeFrame: Whole study period from inclusion to one year after surgery
measure: EORTC-module for fatigue
timeFrame: Whole study period from inclusion to one year after surgery
measure: The Postoperative Recovery Profile
timeFrame: Whole study period from inclusion to one year after surgery
measure: Pancreatic cancer disease impact (PACADI) score
timeFrame: Whole study period from inclusion to one year after surgery
measure: Spirometry
timeFrame: From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
measure: Lenght of stay
timeFrame: From the day before surgery to discharge from the hospital (app 7-14 days)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Göteborg University
Study officials:
References:
citation: Fagevik Olsen M, Becovic S, Dean E. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial. BMC Surg. 2021 Apr 7;21(1):185. doi: 10.1186/s12893-021-01187-2.