Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- the degree of preparation in the colonoscopy (Chicago or Boston scale).
Study 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:
- Compare the three methods of colon preparation for endoscopy
- To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Hepatosplenomegaly
- •Tense ascites
- •hydrothorax, hydropericardium
- •Severe blood coagulation
- •Hemorrhagic vasculitis
- •The patient's refusal to participate in the study
- •Intolerance of specialized clinical nutrition products
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 (Drug)
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 (Dietary Supplement)
Outcomes
Primary Outcomes
the degree of preparation in the colonoscopy (Chicago or Boston scale).
Time Frame: before colonoscopy
Secondary Outcomes
- tolerability(before colonoscopy)