Contact information
Type
Scientific
Contact name
Prof Gabriela Möslein
ORCID ID
Contact details
Klink für Allgemeine und Viszeralchirurgie
Universitätsklinikum Düsseldorf
Düsseldorf
40225
Germany
+49 (0)211/81-16397
moeslein@uni-duesseldorf.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
70-2993 Oh 1
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
HNPCC-associated colorectal carcinoma
Intervention
Subtotal colectomy vs. oncologic resection (restorative proctocolectomy vs rectum resection/extirpation)
Intervention type
Other
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/2002
Overall study end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Germany
Study participating centre
Klink für Allgemeine und Viszeralchirurgie
Düsseldorf
40225
Germany
Sponsor information
Organisation
Deutsche Krebshilfe e. V. - German Cancer Aid (Germany)
Sponsor details
Thomas-Mann-Strasse 40
Bonn
53004
Germany
+49 (0)228/72990-0
deutsche@krebshilfe.de
Sponsor type
Charity
Website
http://www.krebshilfe.de/startseite-dkh.html
ROR
Funders
Funder type
Charity
Funder name
Deutsche Krebshilfe e. V. (70-2993 Oh 1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|