NCT03428724

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

February 5, 2018

Last Update Submit

January 30, 2019

Conditions

Colon Disease

Outcome Measures

Primary Outcomes (1)

  • bowel preparation quality

    Boston bowel preparation score (BBPS)

    1-2 hours after completing bowel preparation

Secondary Outcomes (1)

  • patient comfort during bowel preparation

    1-2 hours after completing bowel preparation

Study Arms (2)

standard group

ACTIVE COMPARATOR

standard polyethylene glycol preparation for colonoscopy

Drug: Standard Preparation

individualized group

EXPERIMENTAL

either a low or a high volume bowel preparation according to patient characteristics

Drug: Individualized Preparation

Interventions

Standard PreparationDRUG

standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)

standard group
Individualized PreparationDRUG

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)

individualized group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective out-patient diagnostic or therapeutic colonoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colentina Clinical Hospital

Bucharest, 020125, Romania

RECRUITING

Carol Davila Emergency Military Hospital

Bucharest, Romania

RECRUITING

MeSH Terms

Conditions

Colonic Diseases

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Study Officials

  • Theodor Voiosu

    Clinical Hospital Colentina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodor Voiosu, MD, PhD

CONTACT

0726732764theodor.voiosu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

February 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

RO(2)