NCT02024022

Brief Summary

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

December 23, 2013

Last Update Submit

January 26, 2016

Conditions

Bowel Cleansing ProcessColonoscopy

Keywords

colonoscopybowel cleansingpolyethylene glycolsodium picosulphate / magnesium citrate

Outcome Measures

Primary Outcomes (1)

  • bowel cleansing

    bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)

    24 hours

Secondary Outcomes (1)

  • patient comfort level during bowel cleansing

    24 hours

Study Arms (2)

Standard approach

ACTIVE COMPARATOR

patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic: * 4L split polyethylene glycol solution * split magnesium citrate/sodium picosulphate preparation regimen

Drug: Standard approach

Individualized approach

EXPERIMENTAL

patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)

Drug: Individualized approach

Interventions

Standard approachDRUG

bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate

Standard approach
Individualized approachDRUG
Also known as: 4 L polyethylene glycol or sodium picosulphate / magnesium citrate
Individualized approach

Eligibility Criteria

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

You may qualify if:

  • all patients \> 18 years of age undergoing elective colonoscopy on an outpatient basis

You may not qualify if:

  • refusal to sign informed consent
  • pregnancy
  • advance kidney, liver or heart disease
  • suspicion of malignant / benign stenosis of the digestive tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor

Cluj-Napoca, Romania

Location

Spitalul CFR

Cluj-Napoca, Romania

Location

Related Publications (1)

  • Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34.

    PMID: 23799210BACKGROUND

MeSH Terms

Interventions

Polyethylene Glycolspicosulfate sodiummagnesium citrate

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Theodor Voiosu, MD, PhD

    Clinical Hospital Colentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, gastroenterology resident

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 31, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

RO(3)