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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03466593
Other study ID # FoU i VGR: 238701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2017
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 245
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Prehabilitation
Prehabilitation concerning eating, smoking, drinking and physical activity
Routine care
Preoperative information
Extra early mobilization
Mobilization the day of surgery
Standard mobilization
Mobilization the day after surgery

Locations

Country Name City State
Sweden Göteborg University Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications Standardized complications according to register Whole study period from inclusion to one year after surgery
Primary PaO2 Arterial oxygen pressure The day before surgery to the first day after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Spirometry Vital capacity From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Secondary Lenght of stay Length of stay at the hospital From the day before surgery to discharge from the hospital (app 7-14 days)
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