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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Adenoma
• Intervention / Treatment: Drug: Polyethylene glycol; Drug: Polyethylene glycol; Drug: Sodium picosulphate with magnesium citrate; Drug: Sodium picosulphate with magnesium citrate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, ASI|KR|KS013|SEOUL
    • Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Same day PEG; group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy	Drug: Polyethylene glycol; -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy; Other Names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea); Drug: Polyethylene glycol; -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; Other Names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Active Comparator: split PEG; 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	Drug: Polyethylene glycol; -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy; Other Names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea); Drug: Polyethylene glycol; -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; Other Names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Active Comparator: SPMC 2; 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	Drug: Sodium picosulphate with magnesium citrate; -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; Other Names: Picolight(Pharmbio korea, Seoul, Korea); Drug: Sodium picosulphate with magnesium citrate; -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.; Other Names: Picolight(Pharmbio korea, Seoul, Korea)
Active Comparator: SPMC 3; 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.	Drug: Sodium picosulphate with magnesium citrate; -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; Other Names: Picolight(Pharmbio korea, Seoul, Korea); Drug: Sodium picosulphate with magnesium citrate; -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.; Other Names: Picolight(Pharmbio korea, Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)	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).	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of the bowel preparation	Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.	30 minutes before the colonoscopy
the patient's tolerability	Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".	30 minutes before the colonoscopy
the side effects of the sodium picosulphate and magnesium citrate	Biochemical measures detected outrange of serum electrolytes (sodium, potassium, chloride, calcium, magnesium, and phosphate), blood urea nitrogen, creatinine and serum osmolality only for the sodium picosulphate and magnesium citrate. Biochemical measurement was done done for the patients in the polyethylene glycol groups due to the well established safety date of the polyethylene glycol solutions.	1 hour before the colonoscopy

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Study Director: Yoon Tae Jeen, Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Principal Investigator: Eun Sun Kim, Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Principal Investigator: Woo Jin Lee, Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Polyethylene glycol; Bowel preparation; Sodium picosulphate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Cathartics; Calcium Chelating Agents; Picosulfate sodium; Citric Acid; Sodium Citrate; Magnesium citrate
• Other Study ID Numbers: Korea University