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| Name | Class |
|---|---|
| Brno University Hospital | OTHER |
| Faculty Hospital Kralovske Vinohrady | OTHER_GOV |
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Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG1D | Active Comparator | Polyethylene glycols single dose a day before colonoscopy |
|
| PEG2D | Active Comparator | Polyethylene glycols split dose |
|
| SPMC1D | Active Comparator | Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy |
|
| SPMC2D | Active Comparator | Natrium picosulfate/ Magnesium citrate split dose |
|
| PEGA1D | Active Comparator | Polyethylene glycol / Ascorbic acid single dose day before colonoscopy |
|
| PEGA2D | Active Comparator | Polyethylene glycol / Ascorbic acid split dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycols | Drug |
| ||
| Natrium picosulfate / Magnesium citrate |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) | One day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Kojecky, MD | Nemocnice T.Bati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital Kralovske Vinohrady | Prague | 10024 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28944412 | Background | Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG1D | Polyethylene glycols single dose a day before colonoscopy Polyethylene Glycols |
| FG001 | PEG2D | Polyethylene glycols split dose Polyethylene Glycols |
| FG002 | SPMC1D | Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy Natrium picosulfate / Magnesium citrate |
| FG003 | SPMC2D | Natrium picosulfate/ Magnesium citrate split dose Natrium picosulfate / Magnesium citrate |
| FG004 | PEGA1D | Polyethylene glycol / Ascorbic acid single dose day before colonoscopy Polyethylene glycol / Ascorbic acid |
| FG005 | PEGA2D | Polyethylene glycol / Ascorbic acid split dose Polyethylene glycol / Ascorbic acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG1D | Polyethylene glycols single dose a day before colonoscopy |
| BG001 | PEG2D | Polyethylene glycols split dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) | Posted | Count of Participants | Participants | One day |
|
0
AE not assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG1D | Polyethylene glycols single dose a day before colonoscopy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kojecky Vladimir | Tomas Bata Hospital | +420577552512 | kojecky@bnzlin.cz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2016 | Oct 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C110422 | magnesium citrate |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Drug |
|
| Polyethylene glycol / Ascorbic acid | Drug |
|
| Lost to Follow-up |
|
| BG002 |
| SPMC1D |
Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy |
| BG003 | SPMC2D | Natrium picosulfate/ Magnesium citrate split dose |
| BG004 | PEGA1D | Polyethylene glycol / Ascorbic acid single dose day before colonoscopy |
| BG005 | PEGA2D | Polyethylene glycol / Ascorbic acid split dose |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG003 | SPMC2D | Natrium picosulfate/ Magnesium citrate split dose |
| OG004 | PEGA1D | Polyethylene glycol / Ascorbic acid single dose day before colonoscopy |
| OG005 | PEGA2D | Polyethylene glycol / Ascorbic acid split dose |
|
|
| Secondary | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) | Posted | Count of Participants | Participants | One day |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | PEG2D | Polyethylene glycols split dose | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | SPMC1D | Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | SPMC2D | Natrium picosulfate/ Magnesium citrate split dose | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | PEGA1D | Polyethylene glycol / Ascorbic acid single dose day before colonoscopy | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | PEGA2D | Polyethylene glycol / Ascorbic acid split dose | 0 | 0 | 0 | 0 | 0 | 0 |
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| 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 |