Colorectal Neoplasms Clinical Trial
Official title:
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
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
The study patients are randomized before surgery to receive either synbiotics (Synbiotics group) or placebo (Control group). Equal randomization is accomplished using a computer-generated random allocation schedule. The method of allocation concealment is sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. Both study products are white powders, identical in weight, smell, and taste. Thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period. ;
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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