Colonoscopy
Conditions
Brief summary
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
Detailed description
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.
Interventions
Sponsors
Brno University Hospital
Faculty Hospital Kralovske Vinohrady
Tomas Bata Hospital, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects referred to diagnostic or therapeutic colonoscopy
Exclusion criteria
* ileus * known or suspected bowel obstruction * active bowel inflammation * pregnancy * any presence of serious medical conditions * history of prior colonic or rectal surgery * inability to obtain valid data from subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | One day | Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | One day | Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEG1D Polyethylene glycols single dose a day before colonoscopy | 160 |
| PEG2D Polyethylene glycols split dose | 162 |
| SPMC1D Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy | 166 |
| SPMC2D Natrium picosulfate/ Magnesium citrate split dose | 159 |
| PEGA1D Polyethylene glycol / Ascorbic acid single dose day before colonoscopy | 169 |
| PEGA2D Polyethylene glycol / Ascorbic acid split dose | 157 |
| Total | 973 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Discontinued intervention | 14 | 10 | 7 | 14 | 4 | 17 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | PEG1D | PEG2D | SPMC1D | SPMC2D | PEGA1D | PEGA2D | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 15.3 | 64.5 years STANDARD_DEVIATION 13.9 | 60.8 years STANDARD_DEVIATION 16.1 | 63.1 years STANDARD_DEVIATION 13.1 | 60.1 years STANDARD_DEVIATION 14.3 | 60.6 years STANDARD_DEVIATION 17 | 62.1 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 162 Participants | 166 Participants | 159 Participants | 169 Participants | 157 Participants | 973 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Czechia | 160 Participants | 162 Participants | 166 Participants | 159 Participants | 169 Participants | 157 Participants | 973 Participants |
| Sex: Female, Male Female | 67 Participants | 70 Participants | 81 Participants | 77 Participants | 67 Participants | 67 Participants | 429 Participants |
| Sex: Female, Male Male | 93 Participants | 92 Participants | 85 Participants | 82 Participants | 102 Participants | 90 Participants | 544 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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)
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEG1D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 110 Participants |
| PEG2D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 145 Participants |
| SPMC1D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 100 Participants |
| SPMC2D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 134 Participants |
| PEGA1D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 121 Participants |
| PEGA2D | Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | 55 Participants |
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)
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEG1D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 56 Participants |
| PEG2D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 72 Participants |
| SPMC1D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 134 Participants |
| SPMC2D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 139 Participants |
| PEGA1D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 85 Participants |
| PEGA2D | Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | 80 Participants |