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Comparison of Preparation Regimens for Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
ClinicalTrials.gov Identifier:
NCT01596686
First received: May 7, 2012
Last updated: February 2, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Colonoscopy Preparation
 Drug: one of two possible colon preparation regimens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Clinical Hospital Colentina:

Primary Outcome Measures:
  • colon preparation [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    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


Enrollment: 184
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Fortrans
  • Picoprep
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:
  • Fortrans
  • Picoprep

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing colonoscopy

Exclusion Criteria:

  • patient refusal to sign informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596686

Locations
Romania
Colentina Clinical Hospital
Bucharest, Romania
Spitalul clinic judetean
Timisoara, Romania, 300783
Sponsors and Collaborators
Clinical Hospital Colentina
  More Information

Publications:

Responsible Party: dr. Theodor Alexandru Voiosu, gastroenterology resident, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT01596686     History of Changes
Other Study ID Numbers: COL-GASTRO-2
Study First Received: May 7, 2012
Last Updated: February 2, 2013
Health Authority: Romania: Ethics Committee

Additional relevant MeSH terms:
Picosulfate sodium
Magnesium citrate
Cathartics
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013