Bowel Preparation Solution, Colonoscopy
Conditions
Brief summary
Comparison of bowel preparation using 2 liter polyethylene glycol regimen plus elobixibat Versus 4-Liter polyethylene glycol regimen. This study based on hypothesis that show Boston bowel preparation scale which 2L PEG regimen plus Elobixibat have result no significant difference from 4L PEG regimen
Detailed description
The trial study in participant who visit to Rajavithi hospital for indication of colonoscopy such as Colorectal cancer screening, Iron deficiency anemia, Chronic diarrhea, chronic constipation, abdominal pain, unintentional weight loss, History of stool occult blood test , abnormal finding from imaging Randomized participant as above in to two group as bowel preparation regimen Group 1 the participant recieved Polyethylene glycol 2 liter split dose plus Elobixibat 10 milligram. Group 2 the participant recieved Polyethylene 4 liter split dose Result of the study show the difference of 2 regimen of bowel preparation which regimen better than another by measuring cleanliness of bowel preparation. The cleanliness of bowel preparation measured by Boston bowel preparation scale
Interventions
DRUG2-Liter polyethylene glycol plus elobixibat
Take Elobixibat 10 mg, one day before colonoscopy at 8 a.m. Take Polyethylene glycol 1 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 1 Liter, at day of colonoscopy at 5 a.m.
DRUG4-Liter polyethylene glycol
Take Polyethylene glycol 2 Liter, one day before colonoscopy at 8 p.m. Take polyethylene glycol 2 Liter, at day of colonoscopy at 5 a.m.
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adute aged 18-80 year old * Indication for colonoscopy(one selected) 1. Colorectal cancer screening 2. Stool occult blood test positive 3. History of colonic polyp 4. abdominal pain 5. Iron deficiency anemia 6. Chronic diarrhea 7. chronic constipation 8. Unintentional weight loss 9. Gastrointestinal bleeding 10. Abnormal imagind study * Participant acceptconsent information
Exclusion criteria
* Pregnancy or lactation * Gastroparesis, gastric outlet obstuction * Bowel obstruction * Gastrointestinal tract surgery * Inflammatory bowel disease * ASA(American society of anesthesiologist physical status) status \> or = 4 * Allergic to Elobixibat or PEG * Chronic kidney disease stage 4-5(GFR \<30 ml/min) * Biliary tract obstruction * Previous history of inadequate bowel preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison efficacy of bowel preparation before colonoscopy between 2 group | During colonoscopy procedure | Bowel preaparation measure by Boston bowel preparation scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal intubation rate | During colonoscopy procedure | Perform successful endoscopy to cecum |
| Withdrawal time of colonoscopy | During colonoscopy procedure | Duration since endoscopy withdrawal from cecum to anal canal |
| Overall procedural time of colonoscopy | During colonoscopy procedure | Duration since start colonoscopy insertion until withdrawal endoscope |
| Patient satisfaction in their bowel preparation regimen | 1 day before colonoscopy | Satisfaction score evaluate by Linkert scale |
| Adverse event in each group | During 24 hour after taking bowel preparation | Nausea, vomiting, abdominal pain, bloating, sleep disturbance, chest pain, dizziness, dyspnea, leg edema |
| Adenoma detection rate | During colonoscopy procedure | At least one adenoma presented in this colonoscopy |
Countries
Thailand
Contacts
Primary ContactApichet Sirinawasatien, M.D.
Backup ContactSomchai Uthiwamek, M.D.
Outcome results
None listed