Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

Promefarm S.r.l.408 enrolled

Overview

It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

408

Conditions

Colonoscopy

Interventions

2L PEG-CS plus bisacodylDRUG

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

2L PEG-ASCDRUG

Patients will asked to take PEG-ASC according to labeling instructions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Out-patients undergoing a complete colonoscopy * Patient written informed consent Exclusion Criteria: * Pregnant or lactating women or at a risk of becoming pregnant * Hypersensitivity to any of the ingredients * History of anaphylaxis to drugs or allergic reactions in general * Known or suspected gastrointestinal obstruction or perforation * Toxic megacolon; major colonic resection * Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study * Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency * Unwillingness to co-operate and to comply with the requirements of the trial

Locations (5)

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

IRCCS Humanitas

Rozzano, Milano, Italy

Spedali Civili

Brescia, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Outcomes

Primary Outcomes

Evaluation of the quality of bowel preparation by BBPS

BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.

Time frame: 20 minutes

Secondary Outcomes

Difference in mucosal visibility between the two groups

Three point rating scale(0-2).

Time frame: 20 minutes

Number of patients with adverse events

Patient questioning.

Time frame: 24 hours

Difference in tolerability between the two groups

Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.

Time frame: 24 hours

Difference in patients acceptability between the two groups

Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation.

Time frame: 24 hours

Difference in patients compliance between the two groups

Difference in the percentage of patients who took at least 75% of bowel preparation.

Time frame: 24 hours

Data from ClinicalTrials.gov

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