Predictive Factors of Inadequate Bowel Preparation in Inpatients (QIPS)

September 2, 2019 updated by: Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)

About 50-70% only of inpatients who undergo colonoscopy have an adequate bowel cleansing, which is far below the recommended threshold of 90%. Variables associated to inadequate colon preparation have not been assessed yet. Identifying such variables would allow to augment the diagnostic yield of colonoscopy, and also to reduce costs related to the need to repeat colonoscopy. Aim of the present study is to find variables independently associated to an inadequate bowel cleansing and to subsequently build and validate a predictive model, which could prove useful in clinical practice to identify hard-to-prepare inpatients. Secondary endpoints are (i) to assess the proportion of patients with inadequate colon cleansing, (ii) to run a cost-effectiveness analysis between patients with adequate cleansing and patients who need to repeat colonoscopy. Patients undergoing urgent colonoscopy, and patients who take the preparation at home will be excluded.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Policlinico Sant'Orsola-Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients hospitalized in 12 Centers in Italy, who are scheduled elective colonoscopy irrespective of the indication.

Description

Inclusion Criteria:

  • Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication.

Exclusion Criteria:

  • Urgent colonoscopy
  • Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inadequate bowel cleansing rate
Time Frame: At the end of the study, 3 months after the beginning of the study.
The number of inpatients with inadequate bowel preparation over the total number of patients enrolled. Bowel prep will be assessed according to the Boston Bowel Preparation Scale (BBPS). A score less than 2 at one segment of the colon will be considered as inadequate bowel preparation.
At the end of the study, 3 months after the beginning of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients scheduled for colonoscopy repetition due to inadequate bowel preparation
Time Frame: At the end of the study, 3 months after the beginning of the study.
Total number of patients scheduled for repeating colonoscopy over the total number of patients enrolled scheduled for repeating colonoscopy due to poor bowel pre.
At the end of the study, 3 months after the beginning of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • QIPS observational study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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