Colon Adenoma, Colorectal Cancer
Conditions
Keywords
Bowel preparation, Polyethylene glycol, Sodium picosulphate
Brief summary
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
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
Interventions
DRUGPolyethylene glycol
-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
DRUGSodium 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
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS) | 20 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of the bowel preparation | 30 minutes before the colonoscopy | Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid. |
| the patient's tolerability | 30 minutes before the colonoscopy | 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. |
| the side effects of the sodium picosulphate and magnesium citrate | 1 hour before the colonoscopy | 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. |
Countries
South Korea
Outcome results
None listed