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OpenTrials
Completed

NCT Number: NCT02839824

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

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.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica de Medicina Integral Diagonal

Esplugues de Llobregat, Barcelona, 08950, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bowel preparation

Procedure

Bowel preparation for bowel cleansing in a real clinical practice

Primary outcomes

  1. Percentage of patients with adequate colon cleansing

    Time frame: Through study completion, an average of 6 months

    Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5

Secondary outcomes

  1. Percentage of patients with adequate colon cleansing of different administration schedules

    Time frame: Through study completion, an average of 6 months

    Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule

  2. Identify factors influencing bowel cleansing quality

    Time frame: 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.

  3. Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents

    Time frame: Through study completion, an average of 6 months

    Relationship between BBPS ≥ 5and the volume of liquid ingestion

  4. Patients' tolerance

    Time frame: Through study completion, an average of 6 months

    Percentage of each adverse event reported per patient in each administration schedule

  5. Quality of bowel cleansing comparison among different bowel cleansing agents

    Time frame: Through study completion, an average of 6 months

    Comparison of percentage of patients with BBPS ≥ 5 between different bowel cleansing agents

  6. Subjects' satisfaction

    Time frame: Through study completion, an average of 6 months

    Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale

Sponsors and collaborators

Lead sponsor

Casen Recordati S.L.

Industry

Registry information

Official study title

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

Acronym: CALICOL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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