Comparison of Bowel Cleansing Regimens Prior to Colonoscopy (PRECOL2011-1)

National Cancer Institute, Naples

Status and phase: Active, not recruiting; Phase 4

Conditions: Patients Undergoing Elective Colonoscopy

Treatments: Drug: polyethylene glycole (PEG) solution; Drug: sodium picosulphate and magnesium citrate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01649674

2011-000587-10 (Registry Identifier)

PRECOL2011-1

Details and patient eligibility

About

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.

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 2 patient groups

PEG

Active Comparator group

Description:

polyethylene glycol solution 2 liters

Treatment:

Drug: polyethylene glycole (PEG) solution

NapP

Active Comparator group

Description:

Sodium picosulphate and magnesium citrate solution 300 ml

Treatment:

Drug: sodium picosulphate and magnesium citrate solution