PMC Split Preparation for Colon Cleansing

Phase 4CompletedNCT01909219

Luigi Sacco University Hospital862 enrolled

Overview

This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy

Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy. Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if \>2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

862

Conditions

Colon Cleansing

Interventions

Sodium picosulphate/magnesium CitrateDRUG

Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * adult outpatients * aged 18-85 yr * undergoing elective colonoscopy Exclusion Criteria: * previous colon resection, * ileus, * intestinal obstruction, * toxic megacolon, * severe heart failure (NYHA Class III or IV), * acute cardiovascular disease, * uncontrolled arterial hypertension (systolic pressure \>170 mmHg, diastolic pressure \>100 mmHg), * severe liver cirrhosis (Child-Pugh score C), * renal failure (creatinine clearance\<30 mL/minute), * ascites, * phenylketonuria, * glucose-6-phosphate dehydrogenase deficiency, * pregnant or breastfeeding women

Locations (2)

Luigi Sacco University Hospital

Milan, Milano, Italy

Luigi Sacco University Hospital

Milan, Italy

Outcomes

Primary Outcomes

Rate of adequate colon cleansing

The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score \> 2 in each colon segment) or "inadequate" (score \< 2 in one or more colon segments

Time frame: 24 hrs

Secondary Outcomes

Patients' acceptance, tolerability and compliance to the cleansing regimen

The overall tolerance of the preparation and the severity of symptoms during the preparation period will be rated on a scale ranging from 0 (no discomfort) to 3 (severe discomfort). Patient acceptance of the preparation will be evaluated by a questionnaire with a 5-point scale ranging from 1 (worse) to 5 (best), assessing interference with daily activity, palatability, easiness in taking the product and the adjunctive clear fluid, and taste of product. Moreover, a nurse will ask the patient whether s/he have completed the prescribed regimen: compliance will be defined as poor for patients who consume less than 75% of product. Willingness to repeat the same preparation in the future will be also recorded.

Time frame: 24 hrs

Data from ClinicalTrials.gov

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