Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy

ASST Fatebenefratelli Sacco

Status and phase: Completed; Phase 4

Conditions: Colon Cleansing for Colonoscopy

Treatments: Drug: sodium picosulphate magnesium citrate; Drug: low-volume PEG -ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01603654

Low volume preparations

Details and patient eligibility

About

Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.

Enrollment: 300 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult outpatients
• aged 18-85 years
• undergoing elective colonoscopy

Exclusion criteria

• previous colon resection
• ileus
• intestinal obstruction
• toxic megacolon
• severe heart failure (New York Heart Association [NYHA] Class III or IV)
• acute cardiovascular disease
• uncontrolled arterial hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
• severe liver failure or ascites
• end-stage renal failure
• phenylketonuria
• glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

sodium picosulphate/magnesium citrate

Experimental group

Treatment:

Drug: sodium picosulphate magnesium citrate

low-volume PEG -ascorbic acid

Active Comparator group

Treatment:

Drug: low-volume PEG -ascorbic acid