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

University of Bologna

Status and phase: Unknown; Phase 4

Conditions: Colon Disease

Treatments: Drug: Macrogol 400; Drug: MoviPrep; Drug: NER1006

Study type: Interventional

Funder types: Other

Identifiers

NCT04708366

INTERPRET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 846 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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846 participants in 3 patient groups

1L PEG

Experimental group

Description:

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

Treatment:

Drug: NER1006

2L PEG

Active Comparator group

Description:

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

Treatment:

Drug: MoviPrep

4L PEG

Active Comparator group

Description:

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

Treatment:

Drug: Macrogol 400