A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024022
• Other study ID #: COL GASTRO 4
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2013
• Last updated: January 26, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion Criteria:

• refusal to sign informed consent

• pregnancy

• advance kidney, liver or heart disease

• suspicion of malignant / benign stenosis of the digestive tract

Study Design

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

Related Conditions & MeSH terms

• Bowel Cleansing Process
• Colonoscopy

Intervention

Drug:
• Standard approach
bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate
• Individualized approach

Locations

Country	Name	City	State
Romania	Colentina Clinical Hospital	Bucharest
Romania	Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor	Cluj
Romania	Spitalul CFR	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

References & Publications (1)

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 polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleansing	bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)	24 hours	No
Secondary	patient comfort level during bowel cleansing	patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process	24 hours	No