Bowel Preparation for Colonoscopy
Conditions
Keywords
bowel cleansing, bowel preparation
Brief summary
Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials. For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.
Interventions
PROCEDUREBowel preparation
Bowel preparation for bowel cleansing in a real clinical practice
Sponsors
Casen Recordati S.L.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Subjects who have been performed a colonoscopy
Exclusion criteria
* Subjects being previously performed colon surgery. * Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy. * Subjects with extreme limitations due to disease. * Subjects in who Boston Bowel Preparation Scale (BBPS) is not available * Subjects who have undergone a colonoscopy during their participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with adequate colon cleansing | Through study completion, an average of 6 months | Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with adequate colon cleansing of different administration schedules | Through study completion, an average of 6 months | Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule |
| Identify factors influencing bowel cleansing quality | Through study completion, an average of 6 months | Relationship between BBPS ≥ 5 and age, gender, ethnicity, weight, height, tobacco consumption, concomitant diseases, medications and indication for colonoscopy in a multivariate analysis. |
| Quality of bowel cleansing comparison among different bowel cleansing agents | Through study completion, an average of 6 months | Comparison of percentage of patients with BBPS ≥ 5 between different bowel cleansing agents |
| Patients' tolerance | Through study completion, an average of 6 months | Percentage of each adverse event reported per patient in each administration schedule |
| Subjects' satisfaction | Through study completion, an average of 6 months | Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale |
| Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents | Through study completion, an average of 6 months | Relationship between BBPS ≥ 5and the volume of liquid ingestion |
Countries
Spain
Outcome results
None listed