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OpenTrials
Completed

NCT Number: NCT03925506

Predictive Factors of Inadequate Bowel Preparation in Inpatients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Sant'Orsola-Malpighi

Bologna, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: QIPS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2019
Registry last updated
Sep 4, 2019

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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