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

NCT03466593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2021-01-05

No results posted yet for this study

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.

Conditions

  • Pancreas Cancer

Interventions

OTHER

Prehabilitation

Prehabilitation concerning eating, smoking, drinking and physical activity

OTHER

Routine care

Preoperative information

OTHER

Extra early mobilization

Mobilization the day of surgery

OTHER

Standard mobilization

Mobilization the day after surgery

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466593 on ClinicalTrials.gov