Skip to main content
OpenTrials
Completed

NCT Number: NCT03466593

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göteborg University

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo pancreatic surgery

Exclusion criteria

in substudy b:

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

Treatment and study plan

Prehabilitation

Other

Prehabilitation concerning eating, smoking, drinking and physical activity

Routine care

Other

Preoperative information

Extra early mobilization

Other

Mobilization the day of surgery

Standard mobilization

Other

Mobilization the day after surgery

Primary outcomes

  1. Postoperative complications

    Time frame: Whole study period from inclusion to one year after surgery

    Standardized complications according to register

  2. PaO2

    Time frame: The day before surgery to the first day after surgery

    Arterial oxygen pressure

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. Spirometry

    Time frame: From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation

    Vital capacity

  7. 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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi

Acronym: PreMob

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.