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van CCT (UK)


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van CCT (UK)


Functional outcomes and quality of life of elderly patients with rectal carcinoma


- candidate number17619
- NTR NumberNTR4551
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-apr-2014
- Secondary IDsM014-003 METC Noord-Holland
- Public TitleFunctional outcomes and quality of life of elderly patients with rectal carcinoma
- Scientific TitleFunctional outcomes and quality of life of elderly patients with rectal carcinoma: should the patient a permanent colostomy or not?
- ACRONYMFQER
- hypothesisThe hypothesis is that a permanent colostomy in elderly patients with rectal carcinoma has no less quality of life compared to elderly patients with a primary anastomosis.
- Healt Condition(s) or Problem(s) studiedRectal cancer, Quality of life, Functional outcome, Stoma
- Inclusion criteria- histological proven rectal carcinoma
- 70 years of age at the time of operation
- elective low anterior resection between 31-12-2007 and 01-01-2014
- Exclusion criteria- acute resection
- transanal endoscopic microsurgery
- abdominoperineal resection
- diagnosed with cognitive impairment
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 24-apr-2014
- planned closingdate1-jan-2015
- Target number of participants80
- InterventionsNone. This is an evaluation study using validated questionnaires that will be self-administered by patients at home.
- Primary outcomeWhat does a patient choose: resection with a primary anastomosis or with a permanent colostomy
- Secondary outcomeQuality of life and functional outcomes, measured with multiple validated questionnaires
- TimepointsThe questionnaires will be sent to eligible patients at home. There will be 2 timepoints of questionnaires.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Reza Indrakusuma
- CONTACT for SCIENTIFIC QUERIES Reza Indrakusuma
- Sponsor/Initiator Noordwest Ziekenhuisgroep
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Alkmaar
- Publications
- Brief summaryElderly patients who have been operated on for rectal carcinoma and received either a primary anastomosis or a permanent colostomy will be invited to participate in an evaluation study. Validated questionnaires will be sent, patients can self-administer these at home.
Mean results of these questionnaires will be grouped according to stoma status and will be shared with the patients.
There will be two time points of questionnaires. The primary outcome will be measured during the second time point.
- Main changes (audit trail)
- RECORD30-apr-2014 - 26-mei-2014


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