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

NCT ID: NCT03466593

Last Updated: 2021-01-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2020-12-31

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:

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.

Detailed Description

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Conditions

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Pancreas Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. A prospective cohort compared to historical controls
2. A randomized, controlled, intervention study.
Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type OTHER

Prehabilitation concerning eating, smoking, drinking and physical activity

Retrospective cohort

Routine care before the prehabilitation program was introduced

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Preoperative information

Extra early mobilization

Mobilization the day of surgery

Group Type EXPERIMENTAL

Extra early mobilization

Intervention Type OTHER

Mobilization the day of surgery

Traditional mobilization

Routine care with mobilization the day after surgery

Group Type ACTIVE_COMPARATOR

Standard mobilization

Intervention Type OTHER

Mobilization the day after surgery

Interventions

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Prehabilitation

Prehabilitation concerning eating, smoking, drinking and physical activity

Intervention Type OTHER

Routine care

Preoperative information

Intervention Type OTHER

Extra early mobilization

Mobilization the day of surgery

Intervention Type OTHER

Standard mobilization

Mobilization the day after surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo pancreatic surgery

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Göteborg University

Gothenburg, , Sweden

Site Status

Countries

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Sweden

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.

Reference Type DERIVED
PMID: 33827537 (View on PubMed)

Other Identifiers

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FoU i VGR: 238701

Identifier Type: -

Identifier Source: org_study_id

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