Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing

Comparison of Three Different Rescue Bowel Preparation Regimens in Patients With Previous Bowel Cleansing Failure at Colonoscopy

The goal of this clinical trial is to learn which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study will also look at how satisfied participants are with each preparation. The main questions it aims to answer are:

• Which bowel preparation helps more participants achieve adequate bowel cleansing before repeat colonoscopy?
• Which bowel preparation leads to better cleansing in different parts of the colon?
• Which bowel preparation is better tolerated by participants?

Researchers will compare 3 rescue bowel preparation regimens to see which one works best for repeat colonoscopy after a previous cleansing failure.

Participants will:

• be randomly assigned to 1 of 3 bowel preparation regimens
• take one of the following regimens before repeat colonoscopy:
• 4 liters of polyethylene glycol (PEG) plus 12 milligrams of bisacodyl
• 1 liter of PEG plus ascorbic acid plus 10 milligrams of bisacodyl
• 2 liters of PEG plus extra PEG taken over the 3 days before colonoscopy
• undergo repeat colonoscopy
• rate their satisfaction with the bowel preparation

Study Overview

• Status: Recruiting
• Conditions: Bowel Cleansing for Colonoscopy; Inadequate Bowel Preparation
• Intervention / Treatment: Drug: Drug; Drug: Drug; Drug: Drug

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Scaglione; Phone Number: +39 360638237; Email: giuseppe.scaglione@aornsanpio.it

Study Locations

• Italy
  • Benevento, Italy
    • Recruiting
    • San Pio Hospital
    • Contact: Giuseppe Scaglione, MD; Phone Number: +39 360638237; Email: giuseppe.scaglione@aornsanpio.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Prior inadequate bowel preparation (adequately performed) requiring repeat colonoscopy
• Scheduled to undergo repeat outpatient colonoscopy
• Ability to provide informed consent

Exclusion Criteria:

• Age younger than 18 years
• Inability to provide informed consent
• Contraindication to any study bowel preparation regimen or colonoscopy
• Known or suspected bowel obstruction or severe gastrointestinal motility disorder
• Pregnancy or breastfeeding
• Participation considered inappropriate by the investigators for clinical or safety reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4 L PEG + bisacodyl; Participants receive 4 L polyethylene glycol (PEG) plus bisacodyl 12 mg before repeat colonoscopy after prior inadequate bowel preparation.	Drug: Drug; 4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; SELG ESSE; Drug: Drug; 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; Plenvu; Drug: Drug; 2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.; Other Names: Clensia
Active Comparator: 1 L PEG plus ascorbic acid + bisacodyl; Participants receive 1 L polyethylene glycol (PEG) plus ascorbic acid and bisacodyl 10 mg before repeat colonoscopy after prior inadequate bowel preparation.	Drug: Drug; 4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; SELG ESSE; Drug: Drug; 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; Plenvu; Drug: Drug; 2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.; Other Names: Clensia
Active Comparator: 2 L PEG + additional PEG; Participants receive 2 L polyethylene glycol (PEG) plus additional PEG administered during the 3 days before repeat colonoscopy after prior inadequate bowel preparation.	Drug: Drug; 4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; SELG ESSE; Drug: Drug; 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.; Other Names: Bisacodyl; Plenvu; Drug: Drug; 2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.; Other Names: Clensia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel preparation at repeat colonoscopy	Proportion of participants with adequate bowel preparation at repeat colonoscopy, defined as a Boston Bowel Preparation Scale (BBPS) total score of 6 or higher, with a score of at least 2 in each colonic segment.	At repeat colonoscopy, on the day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Boston Bowel Preparation Scale score at repeat colonoscopy	Mean total Boston Bowel Preparation Scale (BBPS) score assessed at repeat colonoscopy. The BBPS ranges from 0 to 9, with higher scores indicating better bowel cleansing.	At repeat colonoscopy, on the day of the procedure
Right colon Boston Bowel Preparation Scale subscore	Mean BBPS subscore for the right colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.	At repeat colonoscopy, on the day of the procedure
Transverse colon Boston Bowel Preparation Scale subscore	Mean BBPS subscore for the transverse colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.	At repeat colonoscopy, on the day of the procedure
Left colon Boston Bowel Preparation Scale subscore	Mean BBPS subscore for the left colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.	At repeat colonoscopy, on the day of the procedure
Participant satisfaction with bowel preparation	Participant-reported satisfaction with the assigned bowel preparation regimen, measured using a numerical rating scale. Higher scores indicate greater satisfaction.	Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure
Polyp detection at repeat colonoscopy	Proportion of participants with at least 1 polyp detected during repeat colonoscopy.	At repeat colonoscopy, on the day of the procedure

Collaborators and Investigators

• Sponsor: Ospedale San Pio

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; Bowel preparation; Rescue bowel preparation
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Glycols; Ethylene Glycols; Cresols; Bisacodyl; Pharmaceutical Preparations; Polyethylene Glycols
• Other Study ID Numbers: CECN/2116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No