Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing: A Randomized Controlled Trial

NCT07557173 | Recruiting

• 1 other identifier: CECN/2116
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bowel Cleansing for Colonoscopy; Inadequate Bowel Preparation

Keywords

Rescue bowel preparation; Bowel preparation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total Boston Bowel Preparation Scale score at repeat colonoscopy

  At repeat colonoscopy, on the day of the procedure

• Right colon Boston Bowel Preparation Scale subscore

  At repeat colonoscopy, on the day of the procedure

• Transverse colon Boston Bowel Preparation Scale subscore

  At repeat colonoscopy, on the day of the procedure

• Left colon Boston Bowel Preparation Scale subscore

  At repeat colonoscopy, on the day of the procedure

• Participant satisfaction with bowel preparation

  Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure

Study Arms (3)

4 L PEG + bisacodyl

ACTIVE COMPARATOR

Participants receive 4 L polyethylene glycol (PEG) plus bisacodyl 12 mg before repeat colonoscopy after prior inadequate bowel preparation.

Drug: Drug

1 L PEG plus ascorbic acid + bisacodyl

ACTIVE COMPARATOR

Participants receive 1 L polyethylene glycol (PEG) plus ascorbic acid and bisacodyl 10 mg before repeat colonoscopy after prior inadequate bowel preparation.

Drug: Drug

2 L PEG + additional PEG

ACTIVE COMPARATOR

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

Interventions

Drug DRUG

4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.

4 L PEG + bisacodyl

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Pio: lead

Study Sites (1)

San Pio Hospital

Benevento, Italy

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Preparations

Central Study Contacts

Giuseppe Scaglione

CONTACT

+39 360638237; giuseppe.scaglione@aornsanpio.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is open-label for participants, care providers, and investigators. However, the colonoscopist assessing bowel cleansing at repeat colonoscopy was not aware of the assigned bowel preparation regimen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants are randomly assigned in a 1:1:1 ratio to 1 of 3 rescue bowel preparation regimens before repeat colonoscopy after prior inadequate bowel preparation.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: January 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)