A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate

Korea University

Status and phase: Completed; Phase 3

Conditions: Colon Adenoma; Colorectal Cancer

Treatments: Drug: Sodium picosulphate with magnesium citrate; Drug: Polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT01778192

Korea University

Details and patient eligibility

About

Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions.

Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC).

There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.

The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.

Full description

Study design: endoscopist-blinded, prospective, randomized controlled trial

Subjects

Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study. Exclusion criteria:

gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.

Sampling design: Consecutive recruitment of consenting patients

Variables Predictor

group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure; group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure. Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study

Exclusion criteria

• gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Same day PEG

Active Comparator group

Description:

group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy

Treatment:

Drug: Polyethylene glycol

split PEG

Active Comparator group

Description:

group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure

Treatment:

Drug: Polyethylene glycol

SPMC 2

Active Comparator group

Description:

group 3 (SPMC 2, N=50) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure

Treatment:

Drug: Sodium picosulphate with magnesium citrate

SPMC 3

Active Comparator group

Description:

group 4 (SPMC 3, N=50) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.

Treatment:

Drug: Sodium picosulphate with magnesium citrate