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NCT03466593: PreMob

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

Completed NA Last updated 5 January 2021
What this trial tests

NA trial testing Prehabilitation in Pancreas Cancer in 245 participants. Completed in 31 December 2020.

Timeline
18 December 2017
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorGöteborg University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment245
Start date18 December 2017
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Göteborg University

Who can join

Eligibility, any sex, with Pancreas Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A review of physical activity in pancreatic ductal adenocarcinoma: Epidemiology, intervention, animal models, and clinical trials.
    Hsueh HY, Pita-Grisanti V, Gumpper-Fedus K, Lahooti A, et al · · 2022 · cited 17× · PMID 34750076 · DOI 10.1016/j.pan.2021.10.004
  2. The Human Microbiomes in Pancreatic Cancer: Towards Evidence-Based Manipulation Strategies?
    Brandi G, Turroni S, McAllister F, Frega G. · · 2021 · cited 15× · PMID 34576078 · DOI 10.3390/ijms22189914
  3. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial.
    Fagevik Olsén M, Becovic S, Dean E. · · 2021 · cited 13× · PMID 33827537 · DOI 10.1186/s12893-021-01187-2

Verify or expand the search:

Other trials of Prehabilitation

Trials testing the same drug.

Other recruiting trials for Pancreas Cancer

Currently open trials in the same condition.

Other Göteborg University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03466593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing