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

January 4, 2021 updated by: Göteborg University

Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Göteborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Whole study period from inclusion to one year after surgery
Standardized complications according to register
Whole study period from inclusion to one year after surgery
PaO2
Time Frame: The day before surgery to the first day after surgery
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
Time Frame: 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
Whole study period from inclusion to one year after surgery
EORTC-module specific for pancreas cancer
Time Frame: 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
Whole study period from inclusion to one year after surgery
EORTC-module for fatigue
Time Frame: 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
Whole study period from inclusion to one year after surgery
The Postoperative Recovery Profile
Time Frame: 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
Whole study period from inclusion to one year after surgery
Pancreatic cancer disease impact (PACADI) score
Time Frame: 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)
Whole study period from inclusion to one year after surgery
Spirometry
Time Frame: From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Vital capacity
From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Lenght of stay
Time Frame: From the day before surgery to discharge from the hospital (app 7-14 days)
Length of stay at the hospital
From the day before surgery to discharge from the hospital (app 7-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FoU i VGR: 238701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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