Bowel Cleansing for Colonoscopy, Inadequate Bowel Preparation
Conditions
Keywords
Rescue bowel preparation, Bowel preparation, Colonoscopy
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
Interventions
DRUGDrug
4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.
Sponsors
Ospedale San Pio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate bowel preparation at repeat colonoscopy | At repeat colonoscopy, on the day of the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Boston Bowel Preparation Scale score at repeat colonoscopy | At repeat colonoscopy, on the day of the procedure | 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. |
| Right colon Boston Bowel Preparation Scale subscore | At repeat colonoscopy, on the day of the procedure | 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. |
| Transverse colon Boston Bowel Preparation Scale subscore | At repeat colonoscopy, on the day of the procedure | 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. |
| Left colon Boston Bowel Preparation Scale subscore | At repeat colonoscopy, on the day of the procedure | 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. |
| Participant satisfaction with bowel preparation | Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure | Participant-reported satisfaction with the assigned bowel preparation regimen, measured using a numerical rating scale. Higher scores indicate greater satisfaction. |
| Polyp detection at repeat colonoscopy | At repeat colonoscopy, on the day of the procedure | Proportion of participants with at least 1 polyp detected during repeat colonoscopy. |
Countries
Italy
Contacts
CONTACTGiuseppe Scaglione
Outcome results
None listed