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

NCT02839824 | Completed

• 1 other identifier: CAS-EVA-2016-01
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation for Colonoscopy

Keywords

bowel cleansing; bowel preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of patients with adequate colon cleansing of different administration schedules

  Through study completion, an average of 6 months

• Identify factors influencing bowel cleansing quality

  Through study completion, an average of 6 months

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

  Through study completion, an average of 6 months

• Patients' tolerance

  Through study completion, an average of 6 months

• Quality of bowel cleansing comparison among different bowel cleansing agents

  Through study completion, an average of 6 months

Interventions

Bowel preparation PROCEDURE

Bowel preparation for bowel cleansing in a real clinical practice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18-80 years
• Subjects who have been performed a colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casen Recordati S.L.: lead

Study Sites (1)

Clínica de Medicina Integral Diagonal

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

MeSH Terms

Interventions

Cathartics

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ana Bargalló, MD

  Clínica de Medicina Integral Diagonal, Gastroenterology department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: September 15, 2016
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)