The Use of Osmotic Laxatives Versus Macrogol for Bowel Preparation in Patients Undergoing Colonoscopy

NCT04225793 | Unknown

• 1 other identifier: 685476
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The gold standard of colorectal examination is colonoscopy. One of the main purposes of colonoscopy is detecting bowel neoplasms. Right now there are several methods the bowel preparation for the colonoscopy. Several factors can affect the quality of the bowel preparation, such as the kind of oral laxative, the time after its intake and the diet followed in the days before colonoscopy. In this randomized clinical trial the investigators aimed to compare the safety and efficiency of two low-volume laxatives for bowel preparation: potassium, magnesium and sodium sulphates-based laxative Eziclen (IPSEN, France) and Macrogol-3350 + Sodium Sulfate + Potassium Chloride+ Sodium Chloride + Ascorbic Acid-based and Sodium Ascorbate-based Moviprep (Nordgine B.V., The Netherlands)

Conditions

Colorectal Disorders

Keywords

colorectal cancer; colonoscopy; Eziclen

Outcome Measures

Primary Outcomes (1)

• Evaluation of bowel preparation according to Boston Bowel Preparation Scale

  Total score of bowel preparation measured from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. This is evaluated by the endoscopist

  during the procedure

Secondary Outcomes (8)

• Patient compliance to preparation

  1 houre before procedure

• adverse events rate

  starting 1 day before the procedure and within 2 weeks after

• The polyps detection rate

  during the procedure

• Researcher satisfaction with preparation

  during the procedure

• sodium blood level

  one the day before procedure and one houre before procedure

Study Arms (2)

Eziklen®

ACTIVE COMPARATOR

potassium, magnesium and sodium sulphates-based laxative

Drug: Eziklen®

Macrogol

ACTIVE COMPARATOR

Macrogol-3350 + Sodium Sulfate + Potassium Chloride+ Sodium Chloride + Ascorbic Acid-based and Sodium Ascorbate-based Moviprep

Drug: MoviPrep

Interventions

Eziklen® DRUG

The Eziclen solution should be taken in the one-time use regimen in morning before procedure. Consumption of the full volume of the Eziklen® solution of the preparation and the additional amount of water or a clear liquid should be completed at least 2 hours and no later than 4 hours before the procedure.

Also known as: esiclene, Eziklen

Eziklen®

MoviPrep DRUG

The Moviprep® solution should be taken in the one-time use regimen in morning before procedure. Consumption of the full volume of the Moviprep® solution should be completed at least 2 hours and no later than 4 hours before the procedure.

Also known as: Moviprep, macrogol

Macrogol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent forms confirming the understanding of the course of study and agreement to participate in it.
• A written patient consent to fill the prepared questionnaire and to perform diagnostic colonoscopy in case of following situations:
• Routine oncological screening
• Polyps or neoplasms in anamnesis
• Anemia or latent bleeding diagnostics
• Diarrhea or constipation with unknown reason
• Inflammatory bowel disease in remission
• Pathological formation according to US examination (neoplasm evidence in abdomen)
• Suspicious colon neoplasms according to CT and/or irrigography
• ASA scale for physical status assessment ≤ 3
• Patients with adequate electrolyte balance rate (K, Na, Cl, bicarbonate rate screening).
• The baseline data about comorbidities or laboratory data that can jeopardize the safety of the patient or reduce the likelihood of obtaining satisfactory data necessary to achieve the goal (goals) of the study.
• The presence of progressive carcinoma or other bowel disease, leading to excessive mucous membrane fragility.
• The confirmed or suspected gastrointestinal (FA) obstruction, stagnation in the stomach, gastroparesis, or a violation of gastric evacuation.
• The intestinal perforation.

You may not qualify if:

• The pregnancy
• The inability to follow the protocol
• Refuse of study participation.

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead

Study Sites (1)

Clinic of Colorectal and Minimally invasive surgery

Moscow, 119435, Russia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

formyldienolone; MoviPrep; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Inna Tulina, PhD

  Russian Society of Colorectal Surgeons

  STUDY DIRECTOR

• Pavel Pavlov, PhD

  Russian Society of Colorectal Surgeons

  STUDY CHAIR

• Andrey Kiryukhin

  Sechenov State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Garmanova, MD

CONTACT

+79773429249; tatianagarmanova@gmail.com

Daniil Markarian, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: January 13, 2020
• Study Start: June 2, 2019
• Primary Completion: June 2, 2020
• Study Completion: August 2, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)