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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.
Study design: endoscopist-blinded, prospective, randomized controlled trial
Subjects
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
Primary Outcome: Quality of bowel preparation (Ottawa scale)
Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same day PEG | Active Comparator | group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy |
|
| split PEG | Active Comparator | 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 |
|
| SPMC 2 | Active Comparator | 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 |
|
| SPMC 3 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol | Drug | -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Tae Jeen | Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine | Seoul | ASI|KR|KS013|SEOUL | South Korea |
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| Polyethylene glycol | Drug | -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 |
|
|
| Sodium picosulphate with magnesium citrate | Drug | -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 |
|
|
| Sodium picosulphate with magnesium citrate | Drug | -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. |
|
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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 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C005701 | picosulfate sodium |
| C110422 | magnesium citrate |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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