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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:
Researchers will compare 3 rescue bowel preparation regimens to see which one works best for repeat colonoscopy after a previous cleansing failure.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug | Drug | 4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Scaglione | Contact | +39 360638237 | giuseppe.scaglione@aornsanpio.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Pio Hospital | Recruiting | Benevento | Italy |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D001726 | Bisacodyl |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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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.
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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.
| 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. |
|
|
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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |