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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Colorectal Cancer, Colon Adenoma

Intervention / Treatment
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* Drug: Polyethylene glycol
* Drug: Polyethylene glycol
* Drug: Sodium picosulphate with magnesium citrate
* Drug: Sodium picosulphate with magnesium citrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Same day PEG<br>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<br>* -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy<br>* Other names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea);|
| Active Comparator: split PEG<br>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<br>* -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<br>* Other names: Colyte(Taejoon Pharmaceuticals, Seoul, Korea);|
| Active Comparator: SPMC 2<br>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<br>* -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<br>* Other names: Picolight(Pharmbio korea, Seoul, Korea);|
| Active Comparator: SPMC 3<br>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<br>* -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.<br>* Other names: Picolight(Pharmbio korea, Seoul, Korea);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Polyethylene glycol, Sodium picosulphate