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Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

NCT ID: NCT01649674

Last Updated: 2023-03-24

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

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

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Detailed Description

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Conditions

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Patients Undergoing Elective Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEG

polyethylene glycol solution 2 liters

Group Type ACTIVE_COMPARATOR

polyethylene glycole (PEG) solution

Intervention Type DRUG

NapP

Sodium picosulphate and magnesium citrate solution 300 ml

Group Type ACTIVE_COMPARATOR

sodium picosulphate and magnesium citrate solution

Intervention Type DRUG

Interventions

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polyethylene glycole (PEG) solution

Intervention Type DRUG

sodium picosulphate and magnesium citrate solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy

* Informed consent
* Age \> 18 years

Exclusion Criteria

* Previous colonic resection
* Severe inflammatory bowel disease (IBD)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Naples

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valentina D'Angelo, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Mario de Bellis, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Locations

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Presidio Ospedaliero Villa d'Agri

Marsicovetere, , Italy

Site Status

AO Fatebenefratelli ed Oftalmico

Milan, , Italy

Site Status

A.O.U. Seconda Universita di Napoli

Napoli, , Italy

Site Status

Clinica Mediterranea

Napoli, , Italy

Site Status

Istituto Nazionale dei Tumori

Napoli, , Italy

Site Status

Presidio Ospedaliero Ascalesi

Napoli, , Italy

Site Status

Presidio Ospedaliero Maresca

Torre del Greco, , Italy

Site Status

Countries

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Italy

References

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D'Angelo V, Piccirillo MC, Di Maio M, Gallo C, Bucci C, Civiletti C, Di Girolamo E, Marone P, Rossi GB, Tempesta AM, Tracey MC, Romano M, Miranda A, Taranto D, Sessa G, Esposito P, Salerno R, Pumpo R, De Filippo FR, Della Valle E, de Bellis M, Perrone F. A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial. Front Med (Lausanne). 2022 Dec 8;9:1013804. doi: 10.3389/fmed.2022.1013804. eCollection 2022.

Reference Type DERIVED
PMID: 36569131 (View on PubMed)

Other Identifiers

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2011-000587-10

Identifier Type: REGISTRY

Identifier Source: secondary_id

PRECOL2011-1

Identifier Type: -

Identifier Source: org_study_id

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