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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01479907 |
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Date of registration:
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16/11/2011 |
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Primary sponsor: |
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Public title:
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Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
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Scientific title:
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Date of first enrolment:
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November 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01479907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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Greece
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Contacts
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Name:
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George E Theodoropoulos, MD, PhD, FACS |
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Address:
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Telephone:
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+306945463593 |
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Email:
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georgetheocrs@live.com |
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Affiliation:
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Name:
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George E Theodoropoulos, MD, PhD, FACS |
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Address:
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Telephone:
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+306945463593 |
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Email:
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georgetheocrs@live.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Colectomy for histologically proven colorectal adenocarcinoma
Exclusion Criteria:
- Pregnancy,
- hereditary cancer,
- history of inflammatory bowel disease,
- metastatic disease at presentation,
- emergency operation,
- major postoperative complications
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Neoplasms
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Synbiotics
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Primary Outcome(s)
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Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively
[Time Frame: 2 years]
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Secondary ID(s)
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SYNBIOTICSCOLON
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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