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Completed

NCT Number: NCT02714296

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

This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy

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Key information

Conditions

Colonoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ГНЦ колопроктологии

Moscow, 123103, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy
  • The patient's refusal to participate in the study
  • Intolerance of specialized clinical nutrition products

Treatment and study plan

Nutridrink 200 ml

Drug

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

Nutridrink Compact Protein

Dietary Supplement

2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles

Primary outcomes

  1. the degree of preparation in the colonoscopy (Chicago or Boston scale).

    Time frame: before colonoscopy

Secondary outcomes

  1. tolerability

    Time frame: before colonoscopy

    Visual analog scale assessment of tolerability of the preparation to the study

Sponsors and collaborators

Lead sponsor

Nutricia Advanced

Industry

Registry information

Official study title

Phase IV Prospective Sinle Center Randomised Three-arm Controlled Study Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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