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

NCT ID: NCT04708366

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 846 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-05-15

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.

Detailed Description

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%. Such a low efficacy has several negative consequences: first, it leads to repetition of colonoscopy, therefore prolonging patients' in-hospital stay and increasing the risk of adverse events and costs; second, it augments the risk of missing colorectal lesions, negatively affecting patients' management and increasing costs due to the need for adjunctive diagnostic studies.

Current recommendations on bowel preparation among difficult-to-prepare patients are mostly based on expert opinions, the high-volume 4L polyethylene glycol (PEG)-based prep being considered as the gold standard, possibly with further additional solution. On the other hand, compliance to the bowel preparation has been related to an adequate colon cleansing, and it may be argued that inpatients might find it difficult to take high-volume purge. A recent Italian prospective multicentre study among inpatients showed similar rates of adequate bowel preparation between patients who underwent bowel preparation with and without additional solution. 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 randomized multicenter 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.

Conditions

Colon Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1L PEG

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

Group Type: EXPERIMENTAL

NER1006

Intervention Type: 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.

2L PEG

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

Group Type: ACTIVE_COMPARATOR

MoviPrep

Intervention Type: 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.

4L PEG

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

Group Type: ACTIVE_COMPARATOR

Macrogol 400

Intervention Type: 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.

Interventions

NER1006

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.

Intervention Type: DRUG

MoviPrep

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.

Intervention Type: DRUG

Macrogol 400

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.

Intervention Type: DRUG

Other Intervention Names

IMP-1; IMP-2; IMP-3

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Fuccio

Professor of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Fuccio

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

Policlinico Sant'Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Central Contacts

Lorenzo Fuccio

Role: CONTACT

lorenzofuccio@gmail.com

+39 051 2143338

Other Identifiers

INTERPRET

Identifier Type: -

Identifier Source: org_study_id