Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Overview
- Phase
- Phase 4
- Intervention
- Nutridrink 200 ml
- Conditions
- Colonoscopy
- Sponsor
- Nutricia Advanced
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- the degree of preparation in the colonoscopy (Chicago or Boston scale).
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy
Detailed Description
Objective: to improve the quality of bowel preparation for endoscopy. Research objectives: 1. Compare the three methods of colon preparation for endoscopy 2. To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
- •Absence of contraindications to the use of specialized clinical nutrition products
Exclusion Criteria
- •Conditions which are contraindicated for colonoscopy:
- •The acute phase of cerebrovascular accident
- •Acute myocardial infarction
- •severe cardiovascular, pulmonary insufficiency and mixed
- •Violations of the cardiac rhythm (paroxysmal bradyarrhythmia, atrial fibrillation with atrial fibrillation or paroxysmal atrial fibrillation, severe transverse heart block)
- •Severe clinical forms (fulminant) inflammatory diseases of the colon (ulcerative colitis, Crohn's disease, ischemic colitis, radiation colitis, diverticulitis)
- •Aortic aneurysm or heart
- •Acute inflammatory infiltrates abdominal cavity (including diverticulitis)
- •Suspicion of abscess of the abdominal cavity
- •Peritonitis
Arms & Interventions
Group Nutridrink 200ml
50 patients: two days before the investigation is assigned to a diet with the use of specialized clinical nutrition Nutridrink 200 ml 6 bottles per day as a sole source of nutrition. On the day of the colonoscopy, as breakfast, allowed Nutridrink 1-2 bottles
Intervention: Nutridrink 200 ml
Group Nutridrink compact protein
two days before the study is assigned diet with the addition of specialized clinical nutrition Nutridrinc compact protein 125 ml 2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles
Intervention: Nutridrink compact protein
Outcomes
Primary Outcomes
the degree of preparation in the colonoscopy (Chicago or Boston scale).
Time Frame: before colonoscopy
Secondary Outcomes
- tolerability(before colonoscopy)