Bowel Preparation Clinical Trial
Official title:
A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate
Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its
cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG,
some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing
effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the
other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding
bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as
hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated
with SPMC than with PEG.
To enhance the efficacy and reduce the side effects, two studies have evaluated the
combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC
should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same
time.
Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet
of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our
hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG
alone. The tolerability, acceptability and side effects of the 3 regimen will also be
evaluated.
Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1
ratio using a computer-generated sequence. The treatment allocation will be concealed and
revealed by non-research medical personnel at the screening visit.
| Status | Not yet recruiting |
| Enrollment | 600 |
| Est. completion date | May 31, 2020 |
| Est. primary completion date | May 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Eligible patients will include those anticipated to undergo colonoscopy, aged 20 to 80 at the time of enrollment. Exclusion Criteria: - previous colon resection, gastrointestinal obstruction, ileus, intestinal perforation, toxic megacolon, active stage of inflammatory bowel disease, congestive heart failure (New York Heart Association Class III or IV),acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure>100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute) or any allergy to, PEG, or sodium picosulfate solution, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Dalin Tzu Chi General Hospital |
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* Note: There are 23 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Aronchick scale | a validated assessment that describes the visual appearance of the colon on a four-point scale. | through study completion, average 30 minutes | |
| Primary | Boston Bowel Preparation Scale | BBPS is based on the summation of the preparation scores from three segments of the colon (cecum and ascending, transverse colon and left colon). A segment score of 0 describes an"unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared"; segment score 1: "portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and/or opaque liquid"; segment score 2: "minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well"; segment score 3: "entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid". | through study completion, average 30 minutes | |
| Secondary | Adenoma detection rate | when pathology of polyps become available, average in one week. |
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