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

Primary Purpose

Pancreas Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prehabilitation
Routine care
Extra early mobilization
Standard mobilization
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreas Cancer focused on measuring Prehabilitation, Recovery, Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

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

Sites / Locations

  • Göteborg University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Prospective cohort-prehabilitation

Retrospective cohort

Extra early mobilization

Traditional mobilization

Arm Description

A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.

Routine care before the prehabilitation program was introduced

Mobilization the day of surgery

Routine care with mobilization the day after surgery

Outcomes

Primary Outcome Measures

Postoperative complications
Standardized complications according to register
PaO2
Arterial oxygen pressure

Secondary Outcome Measures

EORTC-module generic
Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life
EORTC-module specific for pancreas cancer
Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life
EORTC-module for fatigue
Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life
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
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)
Spirometry
Vital capacity
Lenght of stay
Length of stay at the hospital

Full Information

First Posted
February 23, 2018
Last Updated
January 4, 2021
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03466593
Brief Title
Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
Acronym
PreMob
Official Title
Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Prehabilitation, Recovery, Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective cohort compared to historical controls A randomized, controlled, intervention study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective cohort-prehabilitation
Arm Type
Experimental
Arm Description
A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol.
Arm Title
Retrospective cohort
Arm Type
Active Comparator
Arm Description
Routine care before the prehabilitation program was introduced
Arm Title
Extra early mobilization
Arm Type
Experimental
Arm Description
Mobilization the day of surgery
Arm Title
Traditional mobilization
Arm Type
Active Comparator
Arm Description
Routine care with mobilization the day after surgery
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
Prehabilitation concerning eating, smoking, drinking and physical activity
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Preoperative information
Intervention Type
Other
Intervention Name(s)
Extra early mobilization
Intervention Description
Mobilization the day of surgery
Intervention Type
Other
Intervention Name(s)
Standard mobilization
Intervention Description
Mobilization the day after surgery
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Standardized complications according to register
Time Frame
Whole study period from inclusion to one year after surgery
Title
PaO2
Description
Arterial oxygen pressure
Time Frame
The day before surgery to the first day after surgery
Secondary Outcome Measure Information:
Title
EORTC-module generic
Description
Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life
Time Frame
Whole study period from inclusion to one year after surgery
Title
EORTC-module specific for pancreas cancer
Description
Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life
Time Frame
Whole study period from inclusion to one year after surgery
Title
EORTC-module for fatigue
Description
Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life
Time Frame
Whole study period from inclusion to one year after surgery
Title
The Postoperative Recovery Profile
Description
Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem
Time Frame
Whole study period from inclusion to one year after surgery
Title
Pancreatic cancer disease impact (PACADI) score
Description
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)
Time Frame
Whole study period from inclusion to one year after surgery
Title
Spirometry
Description
Vital capacity
Time Frame
From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Title
Lenght of stay
Description
Length of stay at the hospital
Time Frame
From the day before surgery to discharge from the hospital (app 7-14 days)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Göteborg University
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33827537
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.
Results Reference
derived

Learn more about this trial

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

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