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2017-12-18
2020-12-31
2020-12-31
245
NCT03466593
Göteborg University
Göteborg University
INTERVENTIONAL
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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-02-23 | N/A | 2021-01-04 |
2018-03-08 | N/A | 2021-01-05 |
2018-03-15 | N/A | 2021-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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
|
| ACTIVE_COMPARATOR: Retrospective cohort Routine care before the prehabilitation program was introduced | OTHER: Routine care
|
| EXPERIMENTAL: Extra early mobilization Mobilization the day of surgery | OTHER: Extra early mobilization
|
| ACTIVE_COMPARATOR: Traditional mobilization Routine care with mobilization the day after surgery | OTHER: Standard mobilization
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative complications | Standardized complications according to register | Whole study period from inclusion to one year after surgery |
| PaO2 | Arterial oxygen pressure | The day before surgery to the first day after surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| EORTC-module generic | 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 | 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 | 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 | 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 | 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 | Vital capacity | From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation |
| Lenght of stay | Length of stay at the hospital | From the day before surgery to discharge from the hospital (app 7-14 days) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
