NCT02908919

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

September 9, 2016

Last Update Submit

November 1, 2016

Conditions

Bowel PreparationColonoscopy

Keywords

ColonoscopyPicosulfate sodiumPolyethylene glycolMagnesium citrateAscorbic acidSPMC (solution picosulfate + magnesium citrate)PEGA (Polyethylene glycol + ascorbic acid)

Outcome Measures

Primary Outcomes (1)

  • Quality of bowel preparation according to time intervals of bowel preparation

    The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good

    One day

Secondary Outcomes (1)

  • Tolerance of bowel preparation according to time intervals of bowel preparation

    One day

Study Arms (3)

Fortrans pulv. sol

ACTIVE COMPARATOR

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

Procedure: Colonoscopy

Picoprep pulv. sol.

ACTIVE COMPARATOR

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

Procedure: Colonoscopy

Moviprep pulv. sol.

ACTIVE COMPARATOR

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

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE

The quality of bowel preparation, which is checked during colonoscopy

Fortrans pulv. solMoviprep pulv. sol.Picoprep pulv. sol.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- subjects referred to diagnostic or therapeutic colonoscopy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

RECRUITING

Nemocnice T.Bati

Zlín, 76275, Czechia

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Jan Matous, MD

    Faculty Hospital Kralovske Vinohrady, Prague

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Matous, MD

CONTACT

+420267163680jan.matous1@fnkv.cz

Vladimír Kojecky, MD,PhD

CONTACT

+420577552512kojecky@bnzlin.cz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jan Matous, MD

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 21, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(2)