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Recruiting NCT07557173

Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing

No phase Interventional Bowel Cleansing for Colonoscopy Inadequate Bowel Preparation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug, Drug, Drug.
Who it may be relevant to
Registry conditions: Bowel Cleansing for Colonoscopy, Inadequate Bowel Preparation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug Drug
    4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.
  • Drug Drug
    1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.
  • Drug Drug
    2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.

Primary outcome measures

  • Adequate bowel preparation at repeat colonoscopy [Time frame: At repeat colonoscopy, on the day of the procedure]
Secondary outcome measures (6)
  • Total Boston Bowel Preparation Scale score at repeat colonoscopy [Time frame: At repeat colonoscopy, on the day of the procedure]
  • Right colon Boston Bowel Preparation Scale subscore [Time frame: At repeat colonoscopy, on the day of the procedure]
  • Transverse colon Boston Bowel Preparation Scale subscore [Time frame: At repeat colonoscopy, on the day of the procedure]
  • Left colon Boston Bowel Preparation Scale subscore [Time frame: At repeat colonoscopy, on the day of the procedure]
  • Participant satisfaction with bowel preparation [Time frame: Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure]
  • Polyp detection at repeat colonoscopy [Time frame: At repeat colonoscopy, on the day of the procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • San Pio Hospital — Benevento

Identifiers

NCT: NCT07557173 · CECN/2116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗