Back to resultsIndividualized Bowel Preparation for Colonoscopy (PREP2TARGET)
Primary Purpose
Colon Disease
Status
Unknown status
Phase
Phase 4
Locations
Romania
Study Type
Interventional
Intervention
Standard Preparation
Individualized Preparation
Sponsored by
About this trial
This is an interventional treatment trial for Colon Disease
Eligibility 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;
Sites / Locations
- Colentina Clinical HospitalRecruiting
- Carol Davila Emergency Military HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard group
individualized group
Arm Description
standard polyethylene glycol preparation for colonoscopy
either a low or a high volume bowel preparation according to patient characteristics
Outcomes
Primary Outcome Measures
bowel preparation quality
Boston bowel preparation score (BBPS)
Secondary Outcome Measures
patient comfort during bowel preparation
0-10 patient comfort score using a standard visual-analogue scale
Full Information
NCT ID
NCT03428724
First Posted
February 5, 2018
Last Updated
January 30, 2019
Sponsor
Clinical Hospital Colentina
1. Study Identification
Unique Protocol Identification Number
NCT03428724
Brief Title
Individualized Bowel Preparation for Colonoscopy
Acronym
PREP2TARGET
Official Title
A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Colentina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard group
Arm Type
Active Comparator
Arm Description
standard polyethylene glycol preparation for colonoscopy
Arm Title
individualized group
Arm Type
Experimental
Arm Description
either a low or a high volume bowel preparation according to patient characteristics
Intervention Type
Drug
Intervention Name(s)
Standard Preparation
Intervention Description
standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)
Intervention Type
Drug
Intervention Name(s)
Individualized Preparation
Intervention Description
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)
Primary Outcome Measure Information:
Title
bowel preparation quality
Description
Boston bowel preparation score (BBPS)
Time Frame
1-2 hours after completing bowel preparation
Secondary Outcome Measure Information:
Title
patient comfort during bowel preparation
Description
0-10 patient comfort score using a standard visual-analogue scale
Time Frame
1-2 hours after completing bowel preparation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theodor Voiosu, MD, PhD
Phone
0726732764
Email
theodor.voiosu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodor Voiosu
Organizational Affiliation
Clinical Hospital Colentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreea Bengus, MD
Phone
0040744497626
Email
andreeabengus@yahoo.com
First Name & Middle Initial & Last Name & Degree
Theodor A Voiosu, MD
Facility Name
Carol Davila Emergency Military Hospital
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasile Balaban, MD, PhD
Phone
00400742519793
Email
vbalaban@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Individualized Bowel Preparation for Colonoscopy
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