Efficacy And Tolerability Of Asymmetric Split Regimen For Bowel Preparation

NCT06916689 | Completed

• 1 other identifier: 101-17022023
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and surveillance colonoscopy using a very low volume bowel preparation (1L PEG+Ascorbate). Consecutive outpatients undergoing screening and surveillance colonoscopy were enrolled in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (0,75 L of PEG + ASC the day before and 0,25 L 2:30 hours before colonoscopy); group B, symmetric split dose regimen (0,5 L of PEG + ASC the day before and 0,5 L 3 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a validated, nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.

Conditions

Colon Preparation; Polyps Colorectal

Keywords

Asymmetric split regimen; Bowel preparation; Colon cleansing; Very low volume preparation; 1L PEG + ascorbate

Outcome Measures

Primary Outcomes (1)

• Quality of bowel prepreparation

  Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale. Each segment of the colon received a score from 0 to 3, and these segment scores were summed for a total BBPS score ranging from 0 to 9. The preparation was considered adequate when BBPS score was ≥ 6 with a score with at least 2 points in any segment

  2 days

Secondary Outcomes (4)

• Adenoma detection rate

  2 days

• Rate of the occurrence of adverse events

  2 days

• Compliance

  2 days

• Tolerability of the preparation, as reported by the patient on a Validated Questionnaire

  2 days

Study Arms (2)

Asymmetric split dose preparation

EXPERIMENTAL

75% of the dose is given on the day before of the procedure and 25% of the dose is given on the day of the procedure

Drug: 1L PEG-Asc

Symmetric split dose preparation

ACTIVE COMPARATOR

50% of the dose is given on the day before of the procedure and 50% of the dose is given on the day of the procedure

Drug: 1L PEG-Asc

Interventions

1L PEG-Asc DRUG

PEG 3350 plus sodium sulfate plus sodium chloride plus potassium chloride plus ascorbic acid plus sodium ascorbate

Asymmetric split dose preparation; Symmetric split dose preparation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled as outpatient for screening or surveillance colonoscopy

You may not qualify if:

• Inpatients
• refusal of split dose regimen for bowel preparation
• previous history of colorectal resection
• severe cardiac disease
• advanced (stage IV and V) chronic kidney disease
• pregnancy; ileus
• suspected bowel obstruction or toxic megacolon
• known inflammatory bowel disease
• known or suspected allergy to PEG.

Sponsors & Collaborators

• ASST Rhodense: lead

Study Sites (1)

ASST Rhodense

Garbagnate Milanese, Lombardy, 20020, Italy

Location

Study Officials

• Gianpiero Manes

  ASST Rhodense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Gastroenterology Unit

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: March 8, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 13, 2025

Record last verified: 2023-03

Locations

IT (1)