Individualized Bowel Preparation for Colonoscopy

Colon Disease Clinical Trial

— PREP2TARGET  

Official title:

A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428724
• Other study ID #: COL-GASTRO-6
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2019
• Source: Clinical Hospital Colentina
• Contact: Theodor Voiosu, MD, PhD
• Phone: 0726732764
• Email: theodor.voiosu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective out-patient diagnostic or therapeutic colonoscopy

Exclusion Criteria:

• pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases

Intervention

Drug:
• Standard Preparation
standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)
• Individualized Preparation
individualized bowel preparation for colonoscopy (either split dose 4L PEG or split 2L PEG + ascorbic acid) based o patient characteristics (history of failed bowel preparation; use of laxative drugs, increased BMI, age>65, neurologic comorbidities)

Locations

Country	Name	City	State
Romania	Carol Davila Emergency Military Hospital	Bucharest
Romania	Colentina Clinical Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel preparation quality	Boston bowel preparation score (BBPS)	1-2 hours after completing bowel preparation
Secondary	patient comfort during bowel preparation	0-10 patient comfort score using a standard visual-analogue scale	1-2 hours after completing bowel preparation