Individualized Bowel Preparation for Colonoscopy

NCT ID: NCT03428724

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-11-01

Brief Summary

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

Detailed Description

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Conditions

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Colon Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
single-blind

Study Groups

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standard group

standard polyethylene glycol preparation for colonoscopy

Group Type ACTIVE_COMPARATOR

Standard Preparation

Intervention Type DRUG

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

individualized group

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

Group Type EXPERIMENTAL

Individualized Preparation

Intervention Type DRUG

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)

Interventions

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Standard Preparation

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

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Colentina

OTHER

Sponsor Role lead

Responsible Party

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dr. Theodor Alexandru Voiosu

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodor Voiosu

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Colentina

Locations

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Colentina Clinical Hospital

Bucharest, , Romania

Site Status RECRUITING

Carol Davila Emergency Military Hospital

Bucharest, , Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Theodor Voiosu, MD, PhD

Role: CONTACT

0726732764

Facility Contacts

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Andreea Bengus, MD

Role: primary

0040744497626

Vasile Balaban, MD, PhD

Role: primary

00400742519793

Other Identifiers

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COL-GASTRO-6

Identifier Type: -

Identifier Source: org_study_id

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