Comparison of Preparation Regimens for Colonoscopy

Colonoscopy Preparation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596686
• Other study ID #: COL-GASTRO-2
• Status: Completed
• Phase: N/A
• First received: May 7, 2012
• Last updated: December 23, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients undergoing colonoscopy

Exclusion Criteria:

• patient refusal to sign informed consent

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

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

Locations

Country	Name	City	State
Romania	Colentina Clinical Hospital	Bucharest
Romania	Spitalul clinic judetean	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

References & Publications (2)

Manno M, Pigò 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. — View Citation

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 polyethy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No