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OUTO study


- candidate number24194
- NTR NumberNTR5932
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-apr-2016
- Secondary IDsNL 55694.101.15//NLD20160030 ARB-nummer//sponsor nummer
- Public TitleOUTO study
- Scientific TitlePre operative Optimisation pathway for elderly surgical patients
- ACRONYMOUTO
- hypothesisMulticomponent prehabilition will reduce postoperative adverse events, primary delirium, which will result in less longterm adverse consequences
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Abdominal Aortic Aneurysm, Delirium, Prevention
- Inclusion criteriaall patients of 70 years or older;
all Ethnicities;
male and female;
patients who will be operated on due to colorectal cancer or abdominal aortic aneurysm;
only primary surgery, or patients who had abdominal surgery more than one year ago;
the surgical procedure can be laparoscopic, open or EVAR;
the surgical procedure can be curative or palliative;
patients are capable to fill in answer questionnaires (like WHOQOL-Bref);
patient or attorney –in –fact are capable to give written informed consent.
- Exclusion criteriaemergent or urgent surgical intervention, all patient who do not speak Dutch or English.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2019
- Target number of participants275
- Interventions5 weeks before surgery, physical exercises, dietician advice, complete geriatric assessment and intravenous iron to optimise the patient both physically and mentally.
- Primary outcomedelirium prevention, to reduce delirium to 7.5% in this specific patient group and a shorter duration of the delirium episode
- Secondary outcomelength of hospital stay, ICU admission, functional dependency, qualtity of life and mortality within one year
- Timepointsfollow up on 6 months and 12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Alexa Mosk
- CONTACT for SCIENTIFIC QUERIES Alexa Mosk
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Vifor Pharma
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-apr-2016 - 8-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl