Predictive Factors of Inadequate Bowel Preparation in Inpatients

NCT03925506 | Completed DMC

• 1 other identifier: QIPS observational study
• Study Type: observational
• Target: 1,658
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation Solutions; Colonoscopy; Inpatient

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At the end of the study, 3 months after the beginning of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Policlinico Sant'Orsola-Malpighi

Bologna, Italy

Location

Related Publications (1)

• 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.

  PMID: 32200083 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: February 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

IT (1)