Colonoscopy
Conditions
Brief summary
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
Interventions
DRUGSodium phosphate
32 tablets
Sponsors
Laboratoires Mayoly Spindler
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject who signed an informed consent to participate in the trial. * Subject affiliated with Social Security * Men and women aged 18 to 75 years. * Subject with an indication of scheduled outpatient colonoscopy. * colonoscopy performed within six hours after the second sequence COLOKIT®. * Subject able to swallow tablets.
Exclusion criteria
1. Women pregnant or likely to be (without contraception) or nursing. 2. Subject having any of the following diseases or conditions: * allergy or hypersensitivity to the product tested or any of its excipients, * nausea, vomiting or abdominal pain, * clinically significant renal failure, * primary hyperparathyroidism associated with hypercalcemia, * congestive heart failure, * ascites, * a known or suspected bowel obstruction, * megacolon (congenital or acquired) * intestinal perforation, * ileus, * an inflammatory disease or suspected inflammatory bowel disease, * swallowing disorders, * known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus), * diabetes mellitus (insulin or non insulin-dependent) * a history of gastric surgery (partial or total) * a contraindication to the anesthesia required for the completion of the colonoscopy, * Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a residual antral volume lower than 20 mL | after 2nd treatment regimen intake |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | After drug intake |
| Acceptability of COLOKIT®. | After drug intake |
| Colonoscopy results | After colonoscopy. |
Countries
France
Outcome results
None listed