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出境医 / 临床实验 / Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined
Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bowel Preparation | Drug: PEG Drug: PEG plus SPMC Drug: SPMC | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | May 31, 2020 |
| Estimated Study Completion Date : | May 31, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: PEG group
Patients in the PEG group were instructed to take the first sachet of PEG at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.
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Drug: PEG
2 sachets of PEG will be used as the bowel prep regimen.
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Active Comparator: PEG plus SPMC group
Patients in the PEG plus SPMC group will be instructed to take the SPMC sachet at 19:00 hours the day before colonoscopy and the PEG sachet at 6:00 hours on the morning of the day of colonoscopy.
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Drug: PEG plus SPMC
one sachet of PEG and one sachet will be administered as the bowel prep regimen
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Active Comparator: SPMC group
Patients in the SPMC group were instructed to take the first sachet of SPMC at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.
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Drug: SPMC
2 sachets will be administered as the bowel prep regimen.
|
Outcome Measures
Primary Outcome Measures :
- Aronchick scale [ Time Frame: through study completion, average 30 minutes ]a validated assessment that describes the visual appearance of the colon on a four-point scale.
- Boston Bowel Preparation Scale [ Time Frame: through study completion, average 30 minutes ]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".
Secondary Outcome Measures :
- Adenoma detection rate [ Time Frame: when pathology of polyps become available, average in one week. ]
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Contacts
| Contact: Yu-Hsi Hsieh, MD | 886-5-2648000 ext 5204 | hsiehyuhsi1112@gmail.com |
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
| Principal Investigator: | Yu-Hsi Hsieh, MD | Buddhist Dalin Tzu Chi Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||
| First Posted Date ICMJE | May 28, 2019 | ||||
| Last Update Posted Date | May 28, 2019 | ||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | May 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Adenoma detection rate [ Time Frame: when pathology of polyps become available, average in one week. ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined | ||||
| Official Title ICMJE | A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Bowel Preparation | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
600 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 31, 2020 | ||||
| Estimated Primary Completion Date | May 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03965182 | ||||
| Other Study ID Numbers ICMJE | A10801001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Dalin Tzu Chi General Hospital | ||||
| Study Sponsor ICMJE | Dalin Tzu Chi General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Dalin Tzu Chi General Hospital | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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