Comparison of Preparation Regimens for Colonoscopy

NCT ID: NCT01596686

Last Updated: 2013-12-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-02-28

Brief Summary

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The investigators intend to study the impact of two different preparation regimens for colonoscopy (PEG vs sodium picosulphate) on the quality of the endoscopy as well as patient tolerability.

Detailed Description

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Conditions

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Colonoscopy Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sodium picosulphate and magnesium citrate (Picoprep)

Group Type ACTIVE_COMPARATOR

one of two possible colon preparation regimens

Intervention Type DRUG

Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate

polyethylene glycol (Fortrans)

Group Type ACTIVE_COMPARATOR

one of two possible colon preparation regimens

Intervention Type DRUG

Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate

Interventions

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one of two possible colon preparation regimens

Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate

Intervention Type DRUG

Other Intervention Names

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Fortrans Picoprep

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing colonoscopy

Exclusion Criteria

* patient refusal to sign informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Colentina

OTHER

Sponsor Role lead

Responsible Party

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dr. Theodor Alexandru Voiosu

gastroenterology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Colentina Clinical Hospital

Bucharest, Bucharest, Romania

Site Status

Spitalul clinic judetean

Timișoara, Timisoara, Romania

Site Status

Countries

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Romania

References

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Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26.

Reference Type BACKGROUND
PMID: 22456624 (View on PubMed)

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.

Reference Type RESULT
PMID: 23799210 (View on PubMed)

Other Identifiers

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COL-GASTRO-2

Identifier Type: -

Identifier Source: org_study_id