Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation

NCT ID: NCT02908919

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.

Detailed Description

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Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.

Conditions

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Bowel Preparation Colonoscopy

Keywords

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Colonoscopy Picosulfate sodium Polyethylene glycol Magnesium citrate Ascorbic acid SPMC (solution picosulfate + magnesium citrate) PEGA (Polyethylene glycol + ascorbic acid)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fortrans pulv. sol

Polyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day.

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

The quality of bowel preparation, which is checked during colonoscopy

Picoprep pulv. sol.

Natrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day.

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

The quality of bowel preparation, which is checked during colonoscopy

Moviprep pulv. sol.

Polyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day.

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type PROCEDURE

The quality of bowel preparation, which is checked during colonoscopy

Interventions

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Colonoscopy

The quality of bowel preparation, which is checked during colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- subjects referred to diagnostic or therapeutic colonoscopy.

Exclusion Criteria

* ileus
* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
* history of prior colonic or rectal surgery
* inability to obtain valid data from
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nemocnice T.Bati, Zlin

UNKNOWN

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Motol

OTHER

Sponsor Role collaborator

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role lead

Responsible Party

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MUDr. Jan Matous

Jan Matous, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Matous, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty Hospital Kralovske Vinohrady, Prague

Locations

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Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status RECRUITING

Nemocnice T.Bati

Zlín, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Matous, MD

Role: CONTACT

Phone: +420267163680

Email: [email protected]

Vladimír Kojecky, MD,PhD

Role: CONTACT

Phone: +420577552512

Email: [email protected]

Facility Contacts

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Jan Matous, MD

Role: primary

Vladimir Kojecky, MD,PhD

Role: primary

Other Identifiers

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CB1601

Identifier Type: -

Identifier Source: org_study_id