Ulcerative Colitis Clinical Trial
Official title:
Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | July 26, 2020 |
Est. primary completion date | July 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with Ulcerative Colitis - Patients undergoing elective outpatient colonoscopy - Patients consenting to the study Exclusion Criteria: - Age less than 18 years - Pregnant or lactating women - Significant gastroparesis - Gastric outlet obstruction - Ileus - Known or suspected bowel obstruction or perforation - Phenylketonuria - Toxic colitis or megacolon - Having a stoma - Compromised swallowing reflex or mental status - Psychiatric disease or known or suspected poor compliance - Severe chronic renal failure (creatinine clearance <30 mL/minute) - Severe congestive heart failure (New York Heart Association [NYHA] class III or IV) - Dehydration - Laxative use or dependency - Chronic constipation (<3 spontaneous bm/week) - Uncontrolled hypertension (systolic blood pressure =170 mm Hg, diastolic blood pressure =100 mm Hg) - Prior colon resection - Age above 65 years - Profusely bleeding patients with severe UC |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 |
1 year | |
Secondary | 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. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. |
1 year | |
Secondary | Assessment of adherence to protocol | Patients will answer a set of questions in a data collection sheet pertaining to | 1 year |
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