Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOspedale San Pio
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Drug
Drug4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.
Drug
Drug1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.
Drug
Drug2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: 4 L PEG + bisacodylActive comparator 1 intervention
Group B: 1 L PEG plus ascorbic acid + bisacodylActive comparator 1 intervention
Group C: 2 L PEG + additional PEGActive comparator 1 intervention
Trial outcomes
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.
Time frame
At repeat colonoscopy, on the day of the procedureSecondary outcomes
1
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.
Time frame
At repeat colonoscopy, on the day of the procedure2
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.
Time frame
At repeat colonoscopy, on the day of the procedure3
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.
Time frame
At repeat colonoscopy, on the day of the procedure4
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.
Time frame
At repeat colonoscopy, on the day of the procedureSponsors and contacts
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Source ClinicalTrials.gov