Comparison of Preparation Regimens for Colonoscopy
1 other identifier
interventional
184
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedDecember 24, 2013
December 1, 2013
7 months
May 7, 2012
December 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
colon preparation
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
Study Arms (2)
sodium picosulphate and magnesium citrate (Picoprep)
ACTIVE COMPARATORpolyethylene glycol (Fortrans)
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- all patients undergoing colonoscopy
You may not qualify if:
- patient refusal to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Colentina Clinical Hospital
Bucharest, Bucharest, Romania
Spitalul clinic judetean
Timișoara, Timisoara, 300783, Romania
Related Publications (2)
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.
PMID: 22456624BACKGROUNDVoiosu 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: 23799210RESULT
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- gastroenterology resident
Study Record Dates
First Submitted
May 7, 2012
First Posted
May 11, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
December 24, 2013
Record last verified: 2013-12