Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Dietary Supplement: Nutridrink compact protein; Drug: Nutridrink 200 ml

• Registration Number: NCT02714296
• Lead Sponsor: Nutricia Advanced

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-21
• Primary Completion: 2016-09
• Study Completion: 2016-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
2. Absence of contraindications to the use of specialized clinical nutrition products

Exclusion Criteria

1. 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

2. Pregnancy

3. The patient's refusal to participate in the study

4. Intolerance of specialized clinical nutrition products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Nutridrink compact protein	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
Group Nutridrink 200ml	Nutridrink 200 ml	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

Primary Outcome Measures

Name	Time	Method
the degree of preparation in the colonoscopy (Chicago or Boston scale).	before colonoscopy

Secondary Outcome Measures

Name	Time	Method
tolerability	before colonoscopy	Visual analog scale assessment of tolerability of the preparation to the study

Trial Locations

Locations (1)

ГНЦ колопроктологии; 🇷🇺 Moscow, Russian Federation