Clinical trial NCT03965182: Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined
Official title: A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Keywords: colon preparation, ,
polyethylene glycol
sodium picosulfate/magnesium citrate
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aronchick scale
timeFrame: through study completion, average 30 minutes
measure: Boston Bowel Preparation Scale
timeFrame: through study completion, average 30 minutes
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: when pathology of polyps become available, average in one week.
Other outcomes:
Locations:
Study officials:
affiliation: Buddhist Dalin Tzu Chi Hospital
name: Yu-Hsi Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
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