A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods

Study Overview
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Brief Summary
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Colonoscopy is a common screening method to detect polyps and CRC. With the early detection of CRC through screening colonoscopy, patients could have better therapeutic effects and outcomes. In population screening programs, an increase in completed colonoscopies is related to a decrease in mortality from CRC. However, the miss rate for detecting colorectal neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel preparation results in the relatively low rate of detection of polyps and CRC, because poor preparation interferes with successful colon mucosa examination during a colonoscopy. Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4 liter polyethylene glycol. However, studies comparing the superiority between low-volume bowel preparations are rare, and results are controversial. This study aimed to compare the bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid.

Detailed Description
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Study design: endoscopist-blinded, prospective, randomized controlled trial Subjects Entry criteria: Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study. Exclusion criteria: patients who had chronic kidney disease, severe heart failure(New York Heart Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation. Sampling design: Consecutive recruitment of consenting patients Variables Predictor group 1 (SPMC 2) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure group 2 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure; Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick scale, bubble score) Secondary Outcome: Tolerability, palatability

Official Title
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A Randomized, Prospective Tiral on Efficacy and Tolerability of Low-volume Bowel Preparation Methods for Colonoscopy

Conditions
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Colorectal Cancer, Colon Adenoma

Intervention / Treatment
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* Drug: PEG-Asc
* Drug: SPMC 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study Exclusion Criteria: patients who had chronic kidney disease, severe heart failure(New York Heart Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: PEG-Asc<br>group 1 (PEG-Asc, N=100) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure | Drug: PEG-Asc<br>* received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure<br>* Other names: Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea;|
| Active Comparator: SPMC 2<br>group 2 (SPMC 2, N=100) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure | Drug: SPMC 2<br>* received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 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 Preparation Scale | Preparation Scale | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, Polyethylene glycol with ascorbic acid, Sodium picosulfate with magnesium citrate