Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
NCT ID: NCT01479907 Phase: NA Status: COMPLETED Enrollment: 100 Completion: 2015-09
Conditions
Colorectal Neoplasms
Interventions
Synbiotics, Placebo
Summary
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
Primary Outcome
Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively