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A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy


Phase 3
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Colon Adenoma

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Trial Information

A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy


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

2. Subjects

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

2. 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.

3. Sampling design: Consecutive recruitment of consenting patients

4. Variables Predictor

1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day
of the colonoscopy

2. 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

3. 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;

4. 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.

5. Primary Outcome: Quality of bowel preparation (Ottawa scale)

6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)

Outcome Description:

Immediately following the colonoscopy, the endoscopist who were unaware of the preparation regimen scored the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS).

Outcome Time Frame:

20 minutes

Safety Issue:

No

Principal Investigator

Yoon Tae Jeen

Investigator Role:

Study Director

Investigator Affiliation:

Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

Authority:

Korea: Ministry for Health, Welfare and Family Affairs

Study ID:

Korea University

NCT ID:

NCT01778192

Start Date:

July 2012

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • Colon Adenoma
  • Bowel preparation
  • Polyethylene glycol
  • Sodium picosulphate
  • Adenoma
  • Colorectal Neoplasms

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