An observational study in Bowel Preparation for Colonoscopy, sponsored by Casen Recordati S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-26.
Sponsored by Casen Recordati S.L. · Observational
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.
Casen Recordati S.L. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria
Exclusion Criteria:
Bowel preparation for bowel cleansing in a real clinical practice
Percentage of patients with adequate colon cleansing
Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5
Time frame: Through study completion, an average of 6 months
Percentage of patients with adequate colon cleansing of different administration schedules
Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule
Time frame: Through study completion, an average of 6 months
Identify factors influencing bowel cleansing quality
Relationship between BBPS ≥ 5 and age, gender, ethnicity, weight, height, tobacco consumption, concomitant diseases, medications and indication for colonoscopy in a multivariate analysis.
Time frame: Through study completion, an average of 6 months
Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents
Relationship between BBPS ≥ 5and the volume of liquid ingestion
Time frame: Through study completion, an average of 6 months
Patients' tolerance
Percentage of each adverse event reported per patient in each administration schedule
Time frame: Through study completion, an average of 6 months
Quality of bowel cleansing comparison among different bowel cleansing agents
Comparison of percentage of patients with BBPS ≥ 5 between different bowel cleansing agents
Time frame: Through study completion, an average of 6 months
Subjects' satisfaction
Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale
Time frame: Through study completion, an average of 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Casen Recordati S.L.