Bowel Preparation SolutionsQIPSNCT03925506
Predictive Factors of Inadequate Bowel Preparation in Inpatients
An observational study of Bowel Preparation Solutions and Colonoscopy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation Solutions, Colonoscopy, Inpatient
- How many people
- 1,658 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in 12 Centers in Italy, who are scheduled elective colonoscopy irrespective of the indication.
Who may be able to join
- Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication.
Who cannot join
- Urgent colonoscopy
- Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bowel Preparation Solutions, Colonoscopy, Inpatient
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate bowel cleansing rate
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.
Measured: At the end of the study, 3 months after the beginning of the study.
Secondary outcomes (1)
Rate of patients scheduled for colonoscopy repetition due to inadequate bowel preparation
Total number of patients scheduled for repeating colonoscopy over the total number of patients enrolled scheduled for repeating colonoscopy due to poor bowel pre.
Measured: At the end of the study, 3 months after the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Feb 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation SolutionsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,658 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925506
- Sponsor's protocol ID
- QIPS observational study
- Acronym
- QIPS
- Status last verified
- Sep 2019
- First submitted
- 16 Apr 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.
PubMed 32200083
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Factors of Inadequate Bowel Preparation in Inpatients. The Quality-In-Patients Study (QIPS)
- ClinicalTrials.gov ID
- NCT03925506
- Acronym / sponsor ID
- QIPS / QIPS observational study
- Conditions
- Bowel Preparation Solutions, Colonoscopy, Inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,658 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in 12 Centers in Italy, who are scheduled elective colonoscopy irrespective of the indication.
Key inclusion criteria (1 listed)
- Inpatient ≥18 y.o. who are scheduled elective colonoscopy during hospitalization irrespective of the indication.
Key exclusion criteria (2 listed)
- Urgent colonoscopy
- Patients who are not hospitalized when taking bowel preparation or when undergoing colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 32200083Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Preparation Solutions and Colonoscopy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inadequate bowel cleansing rate (time frame: At the end of the study, 3 months after the beginning of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.