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

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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