Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

Patients Undergoing Elective Colonoscopy Clinical Trial

— PRECOL2011-1  

Official title:

PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649674
• Other study ID #: PRECOL2011-1
• Secondary ID: 2011-000587-10
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 525
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Patients Undergoing Elective Colonoscopy

Intervention

Drug:
• polyethylene glycole (PEG) solution

• sodium picosulphate and magnesium citrate solution

Locations

Country	Name	City	State
Italy	Presidio Ospedaliero Villa d'Agri	Marsicovetere
Italy	AO Fatebenefratelli ed Oftalmico	Milano
Italy	A.O.U. Seconda Universita di Napoli	Napoli
Italy	Clinica Mediterranea	Napoli
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Presidio Ospedaliero Ascalesi	Napoli
Italy	Presidio Ospedaliero Maresca	Torre del Greco

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale value	evaluated by two endoscopists who are blinded to treatment assigned at randomization	at time of colonscopy
Primary	patient reported acceptability score	using visual analog scale	just prior to colonscopy
Secondary	percent of bowel cleansing regimen dose assumed as reported by patient		just prior to colonoscopy