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Ulcerative colitis is a chronic condition that results in the inflammation of the colon and rectum. Patients suspected to have ulcerative colitis are diagnosed via colonoscopy. Moreover, colonoscopy is considered to be the preferred procedure for assessing the activity and extent of the disease, as well as monitoring treatment response and development of lesions. Therefore, optimal performance and visualization of mucosal lesions via adequate bowel preparation is essential in such patients. In addition, the nature of the disease and the need for multiple colonoscopies throughout a patient's lifetime makes compliance to repeated procedures difficult.
It is well known that colonoscopy preparations are generally poorly tolerated, disliked and, consequently serve as an additional burden on patients.Polyethylene glycol (PEG), despite being the golden standard, is not very well tolerated. Inadequate bowel preparations are associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly, with missed pathology. A good bowel preparation would need a solution with reasonable volume, acceptable taste, minimal diet restrictions, and easy-to-follow instructions. The strict need for adherence to drinking a relatively large volume of solution preparation may result in poor compliance.
Despite the emergence of several types of low volume preparations, the evidence on the use of such solutions remains sparse. This is especially true in terms of patients' tolerability to the solution, and its relation with adequate bowel preparation during colonoscopy.
The investigator's aim is to assess how small volume preparations such as sodium picosulfate/magnesium citrate (Citrafleet®) enhance participants tolerability to the solution, compliance, and adequacy of bowel preparations when compared to 2L polyethylene glycol + ascorbic acid (MoviPrep®) in patients with Ulcerative Colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrafleet® | Active Comparator | Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. |
|
| MoviPrep® | Active Comparator | Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Picosulfate/Magnesium Citrate Laxative | Drug | ● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the preparation as assessed by a Likert-type scale | Patients will answer a data collection sheet with questions regarding their ability to tolerate the preparation without difficulty. We are using a Likert-type scale from 1 to 5, 1 being completely intolerable and 5 being very easily tolerated. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the preparation as assessed by the Modified Aronchick scale. | A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A description ranging from Poor to Excellent is assigned to the quality of the prepped colon. Poor - Re-preparation required; large amount of fecal residue precludes a complete examination Inadequate - Inadequate but examination completed; enough feces or turbid fluid to prevent a reliable examination; less than 90%mucosa seen Fair - Moderate amount of stool that can be cleared with suctioning permitting adequate evaluation of entire colonic mucosa; more than 90% mucosa seen Good - Small amount of turbid fluid without feces not interfering with examination; more than 90% mucosa seen Excellent - Small amount of clear liquid with clear mucosa seen; more than 95% mucosa seen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ala Sharara, M.D | Contact | 00961893989 | as08@aub.edu.lb | |
| Louma Rustam, M.D | Contact | 00961952395 | lr22@aub.edu.lb |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Recruiting | Beirut | Lebanon |
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| 2L polyethylene glycol/ascorbic acid | Drug |
|
|
|
| 1 year |
| Quality of the preparation as assessed by the Boston Bowel Preparation Scale. | A data collection sheet will be handed to the blinded endoscopist to answer questions related to the quality of the preparation. A score ranging from 0 to 3 is assigned to each of the three segments of the colon: Right colon, Mid colon and Left colon. The scores are calculated as follows: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
| 1 year |
| Assessment of adherence to protocol | Patients will answer a set of questions in a data collection sheet pertaining to | 1 year |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C005701 | picosulfate sodium |
| D011092 | Polyethylene Glycols |
| D001205 | Ascorbic Acid |
| C520497 | MoviPrep |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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