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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03428724
Date of registration: 05/02/2018
Prospective Registration: No
Primary sponsor: Clinical Hospital Colentina
Public title: Individualized Bowel Preparation for Colonoscopy PREP2TARGET
Scientific title: A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
Date of first enrolment: February 1, 2018
Target sample size: 450
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03428724
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Romania
Contacts
Name:     Theodor Voiosu
Address: 
Telephone:
Email:
Affiliation:  Clinical Hospital Colentina
Name:     Theodor Voiosu, MD, PhD
Address: 
Telephone: 0726732764
Email: theodor.voiosu@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

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;



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Colon Disease
Intervention(s)
Drug: Standard Preparation
Drug: Individualized Preparation
Primary Outcome(s)
bowel preparation quality [Time Frame: 1-2 hours after completing bowel preparation]
Secondary Outcome(s)
patient comfort during bowel preparation [Time Frame: 1-2 hours after completing bowel preparation]
Secondary ID(s)
COL-GASTRO-6
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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