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Comparison of Preparation Regimens for Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596686
First Posted: May 11, 2012
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina:

Primary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing colonoscopy

Exclusion Criteria:

  • patient refusal to sign informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596686


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