Randomized controlled study to assess the efficacy of a very low-volume Polyethylene Glycole (PEG 1L) bowel preparation vs. low-volume (2L) and high-volume (4L) PEG-based preparations, among patients who undergo bowel purge for colonoscopy during in hospital stay.

Efficacy of a very low-volume Polyethylene Glycole (PEG 1L) bowel preparation vs. low-volume (2L) and high-volume (4L) PEG-based preparations. A randomized controlled study. - INpatienTs bowEl pReParation RandomizEd Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002799-15-IT

Enrollment

800

Registered

2021-05-24

Start date

2020-09-16

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult in hospital patients who undergo colonoscopy for any medical disease MedDRA version: 21.0 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations

Interventions

Trade Name: MOVIPREP Product Name: MOVIPREP Product Code: [037711] Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Glicole polietilenico CAS Number: 107-21-1 Current Sponsor code: N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult in hospital patients who are scheduled for colonoscopy due to any medical disease, provided that written consent is obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: • Previous colonic surgery • Bowel obstruction, delayed gastric emptying, bowel perforation, toxic megacolon • Phenylketonuria • Glucose-6-phosphate dehydrogenase deficiency • Acute gastrointestinal bleeding • Emergency colonoscopy • Dementia or other diseases requiring administration of bowel preparations via naso-gastric tube • Patients with “Controindications” to bowel preparations as reported in the relevant summary of product characteristics

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Adherence, in terms of percentage of bowel preparation intake, will be evaluated using a 5-point scale, based on the following percentages of intake: 1, 0-25%; 2, 26-50%; 3, 51-75%; 4, 76-90%; 5, 91-100%.; Tolerability of bowle preparations will be evaluated using a 4-point scale (1=worst; 4=excellent) for each outcome.; Safety will be evaluated through identification of adverse drug reactions;Timepoint(s) of evaluation of this end point: During the execution of colonoscopy; During the execution of colonoscopy; During the execution of colonoscopy	—

Measure

Time frame

Secondary end point(s): Adherence, in terms of percentage of bowel preparation intake, will be evaluated using a 5-point scale, based on the following percentages of intake: 1, 0-25%; 2, 26-50%; 3, 51-75%; 4, 76-90%; 5, 91-100%.; Tolerability of bowle preparations will be evaluated using a 4-point scale (1=worst; 4=excellent) for each outcome.; Safety will be evaluated through identification of adverse drug reactions;Timepoint(s) of evaluation of this end point: During the execution of colonoscopy; During the execution of colonoscopy; During the execution of colonoscopy

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Primary

Measure	Time frame
Main Objective: To assess the efficacy of a very low volume (1L) bowel preparation containing polyethilenglycole(PEG)+ascorbate(Asc) vs. low (2L) and high (4L) volume bowel preparations, in hospitalized patients;Secondary Objective: To evaluate adherence to bowel preparations, in terms of percentage of intake. To evaluate tolerability to bowel preparations (nausea, vomiting, abdominal pain, flatulence, taste). To evaluate safety of bowel preparations. To evaluate the percentage of patients who are rescheduled to colonoscopy due to inadequate cleansing. To validate a recently-developed predictive model of cleansing;Primary end point(s): Cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigned a score from 0 (presence of solid stools) to 3 (excellent visualization of colonic mucosa) for each main colonic tracts, i.e. right colon, transverse colon and left colon/rectum. Cleansing will be asessed as inadequate in case of total score <6 or <2 in one tract [Lai, 2009].;Timepoint(s) of evaluation of this end point: During the execution of colonoscopy	—

Measure

Time frame

Main Objective: To assess the efficacy of a very low volume (1L) bowel preparation containing polyethilenglycole(PEG)+ascorbate(Asc) vs. low (2L) and high (4L) volume bowel preparations, in hospitalized patients;Secondary Objective: To evaluate adherence to bowel preparations, in terms of percentage of intake. To evaluate tolerability to bowel preparations (nausea, vomiting, abdominal pain, flatulence, taste). To evaluate safety of bowel preparations. To evaluate the percentage of patients who are rescheduled to colonoscopy due to inadequate cleansing. To validate a recently-developed predictive model of cleansing;Primary end point(s): Cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigned a score from 0 (presence of solid stools) to 3 (excellent visualization of colonic mucosa) for each main colonic tracts, i.e. right colon, transverse colon and left colon/rectum. Cleansing will be asessed as inadequate in case of total score <6 or <2 in one tract [Lai, 2009].;Timepoint(s) of evaluation of this end point: During the execution of colonoscopy

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Countries

Italy

Contacts

Public ContactDipartimento di Scienze Mediche e C

Alma Mater Studiorum Università di Bologna

lorenzo.fuccio3@unibo.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026