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ISRCTN
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ISRCTN17448795
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ClinicalTrials.gov identifier
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Public title
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Hereditary non-polyposis colorectal carcinoma (HNPCC) - a prospective randomized trial for the comparison of prophylactic or extended surgery versus oncological resection in colon or rectum carcinoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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70-2993 Oh 1
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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HNPCC-associated colorectal carcinoma
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Participants - inclusion criteria
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1. Colorectal carcinoma fulfilling the Amsterdam-criteria for HNPCC or
2. Colorectal carcinoma in patients with known pathogenic mismatch repair gene mutation or
3. Colorectal carcinoma at the age of 50 or less and detection of microsatellite instability in a tumor biopsy and
4. Age between 18 and 65 years
5. Operability for subtotal colectomy/(restorative) proctocolectomy as estimated by the surgeon
6. Exclusion of metastases, local resection of the complete tumor likely to be possible
7. Elective tumorsurgical operation
8. Willingness of the patient to participate in surveillance required by the trial
9. Informed consent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Subtotal colectomy vs. oncologic resection (restorative proctocolectomy vs rectum resection/extirpation)
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Deutsche Krebshilfe e. V. (70-2993 Oh 1)
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Trial website
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Publications
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Contact name
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Prof
Gabriela
Möslein
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Address
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Klink für Allgemeine und Viszeralchirurgie
Universitätsklinikum Düsseldorf
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City/town
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Düsseldorf
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Zip/Postcode
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40225
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Country
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Germany
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Tel
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+49 (0)211/81-16397
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Fax
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+49 (0)211/81-19227
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Email
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moeslein@uni-duesseldorf.de
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Sponsor
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Deutsche Krebshilfe e. V. - German Cancer Aid (Germany)
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Address
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Thomas-Mann-Strasse 40
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City/town
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Bonn
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Zip/Postcode
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53004
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Country
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Germany
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Tel
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+49 (0)228/72990-0
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Fax
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+49 (0)228/72990-11
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Email
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deutsche@krebshilfe.de
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Sponsor website:
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http://www.krebshilfe.de/startseite-dkh.html
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Date applied
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09/06/2004
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Last edited
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17/12/2007
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Date ISRCTN assigned
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27/09/2004
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