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

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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Procedure: Bowel preparation

• Study Type: Observational
• Enrollment (Actual): 412

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Clínica de Medicina Integral Diagonal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Patients' tolerance	Percentage of each adverse event reported per patient in each administration schedule	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	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	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Casen Recordati S.L.
• Investigators: Study Director: Ana Bargalló, MD, Clínica de Medicina Integral Diagonal, Gastroenterology department

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): March 6, 2017
• Study Completion (Actual): March 6, 2017

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: bowel preparation; bowel cleansing
• Other Study ID Numbers: CAS-EVA-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO