Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
NCT ID: NCT03466593
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
245 participants
INTERVENTIONAL
2017-12-18
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. A randomized, controlled, intervention study.
PREVENTION
NONE
Study Groups
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Prospective cohort-prehabilitation
A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.
Prehabilitation
Prehabilitation concerning eating, smoking, drinking and physical activity
Retrospective cohort
Routine care before the prehabilitation program was introduced
Routine care
Preoperative information
Extra early mobilization
Mobilization the day of surgery
Extra early mobilization
Mobilization the day of surgery
Traditional mobilization
Routine care with mobilization the day after surgery
Standard mobilization
Mobilization the day after surgery
Interventions
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Prehabilitation
Prehabilitation concerning eating, smoking, drinking and physical activity
Routine care
Preoperative information
Extra early mobilization
Mobilization the day of surgery
Standard mobilization
Mobilization the day after surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Göteborg University
OTHER
Responsible Party
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Locations
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Göteborg University
Gothenburg, , Sweden
Countries
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References
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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.
Other Identifiers
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FoU i VGR: 238701
Identifier Type: -
Identifier Source: org_study_id
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