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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Predictive Factors of Inadequate Bowel Preparation in Inpatients

Clinicaltrials.gov identifier NCT03925506

Recruitment Status Completed

First Posted April 24, 2019

Last update posted September 4, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Inpatient
    Bowel Preparation Solutions
    Colonoscopy
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 1658 participants
  • Observational Model: Case-Only
  • Time Perspective: Cross-Sectional
  • Official Title: Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)
  • Actual Study Start Date: February 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Adult patients hospitalized in 12 Centers in Italy, who are scheduled elective colonoscopy irrespective of the indication.
Criteria

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

Contacts and Locations
Contacts
Locations

Italy
Policlinico Sant'Orsola-Malpighi
Bologna

Sponsors and Collaborators

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

More Information
  • Responsible Party: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  • ClinicalTrials.gov Identifier: NCT03925506 History of Changes
  • Other Study ID Numbers: QIPS observational study
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 4, 2019
  • Last Verified: September 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No