Comparison of Preparation Regimens for Colonoscopy

December 23, 2013 updated by: dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Colentina Clinical Hospital
      • Timisoara, Romania, 300783
        • Spitalul clinic judetean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients undergoing colonoscopy

Exclusion Criteria:

  • patient refusal to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sodium picosulphate and magnesium citrate (Picoprep)
Drug: 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
Other Names:
  • Picoprep
  • Fortrans
Active Comparator: polyethylene glycol (Fortrans)
Drug: 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
Other Names:
  • Picoprep
  • Fortrans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
colon preparation
Time Frame: 24 h
the impact of colon preparation as assessed by the endoscopist (scale from 1 to 4, 1 representing the worst and 4 the best prepared colon) on the quality of the endoscopic examination
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Colentina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL-GASTRO-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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