Colorectal Neoplasms Clinical Trial
Official title:
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Verified date | May 2016 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
The aim of this double-blinded prospective randomised trial is to explore the potential
benefits of early postoperative administration of Synbiotics (combination of prebiotics and
probiotics) to patients who have undergone colectomy for cancer. The patients are randomised
to either synbiotics or placebo administration at the day they are able to tolerate po
liquid diet and for 15 days thereafter.
Primary end points of the study will be:
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months
postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of
Life Index)
Secondary end points will be:
-Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months
postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2015 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Greece | First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively | 2 years | No |
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