Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients

NCT04708366 | Unknown Phase 4

• 1 other identifier: INTERPRET
• Study Type: interventional
• Target: 846
• Locations: 1 country
• Sites: 1

Brief Summary

An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two. Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.

Conditions

Colon Disease

Keywords

colonoscopy; hospitalized patients; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with adequate colon cleansing

  Efficacy will be assessed as the percentage of patients with adequate bowel cleansing, as rated according to the Boston Bowel Preparation Scale (BBPS). This scale gives 0-3 points to each of the three colonic segments (i.e. right colon, transverse colon, and left colon); 0 points are assigned for the worst segment cleansing, whereas at least 2 points stand for adequate segment cleansing. Adequate colon cleansing is defined when at least 2 points are reached in each colonic segment.

  During the procedure.

Study Arms (3)

1L PEG

EXPERIMENTAL

Patients will be prepared with 1L-PEG-based bowel preparation.

Drug: NER1006

2L PEG

ACTIVE COMPARATOR

Patients will be prepared with 2L-PEG-based bowel preparation.

Drug: MoviPrep

4L PEG

ACTIVE COMPARATOR

Patients will be prepared with 4L-PEG-based bowel preparation.

Drug: Macrogol 400

Interventions

NER1006 DRUG

Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.

Also known as: IMP-1

1L PEG

MoviPrep DRUG

Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.

Also known as: IMP-2

2L PEG

Macrogol 400 DRUG

Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.

Also known as: IMP-3

4L PEG

Eligibility Criteria

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

You may qualify if:

• Inpatients scheduled for elective colonoscopy
• bowel preparation performed inside the hospital
• ≥18 years old

You may not qualify if:

• known or suspected ileus
• gastrointestinal obstruction
• gastric retention
• bowel perforation
• toxic colitis, or megacolon
• phenylketonuria
• glucose-6-phosphate dehydrogenase deficiency
• active intestinal bleeding
• emergency colonoscopy
• dementia or illness requiring nasogastric tube for bowel prep administration
• refusal to participate or inability to sign the informed consent

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Policlinico Sant'Orsola-Malpighi

Bologna, Italy

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

MoviPrep; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Lorenzo Fuccio

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Fuccio

CONTACT

+39 051 2143338; lorenzofuccio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 13, 2021
• Study Start: February 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)