Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting

Bowel Preparation for Colonoscopy Clinical Trial

— CALICOL  

Official title:

Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting (CALICOL Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839824
• Other study ID #: CAS-EVA-2016-01
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: January 24, 2018
• Start date: September 15, 2016
• Est. completion date: March 6, 2017

Study information

• Verified date: January 2018
• Source: Casen Recordati S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Procedure:
• Bowel preparation
Bowel preparation for bowel cleansing in a real clinical practice

Locations

Country	Name	City	State
Spain	Clínica de Medicina Integral Diagonal	Esplugues de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Casen Recordati S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with adequate colon cleansing	Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) = 5	Through study completion, an average of 6 months
Secondary	Percentage of patients with adequate colon cleansing of different administration schedules	Percentage of patients with punctuation in BBPS = 5 in each administration schedule	Through study completion, an average of 6 months
Secondary	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.	Through study completion, an average of 6 months
Secondary	Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents	Relationship between BBPS = 5and the volume of liquid ingestion	Through study completion, an average of 6 months
Secondary	Patients' tolerance	Percentage of each adverse event reported per patient in each administration schedule	Through study completion, an average of 6 months
Secondary	Quality of bowel cleansing comparison among different bowel cleansing agents	Comparison of percentage of patients with BBPS = 5 between different bowel cleansing agents	Through study completion, an average of 6 months
Secondary	Subjects' satisfaction	Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale	Through study completion, an average of 6 months