Bowel Preparation
Conditions
Keywords
adenoma, bowel preparation, colonoscopy, predictive model, randomized controlled trial
Brief summary
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.
Interventions
DRUGPolyethylene Glycol
In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-75 years undergoing colonoscopy
Exclusion criteria
* known or suspected bowel obstruction, stricture or perforation * compromised swallowing reflex or mental status * severe chronic renal failure(creatinine clearance \< 30 ml/min) * severe congestive heart failure (New York Heart Association class III or IV) * uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg) * dehydration * disturbance of electrolytes * pregnancy or lactation * hemodynamically unstable * unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Bowel Preparation | 10 months | The quality of bowel preparation is evaluated using BBPS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate | 10 months | The proportion of patients from whom at least one adenoma can be detected. |
| Polyp Detection Rate | 10 months | The proportion of patients from whom at least one polyp can be detected. |
| Adverse Events | 10 months | Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on. |
Countries
China
Outcome results
None listed