Trial Outcomes & Findings for Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy (NCT NCT02956057)

Results Overview

Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1044 participants

Primary outcome timeframe

One day

Results posted on

2020-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	PEG1D Polyethylene glycols single dose a day before colonoscopy Polyethylene Glycols	PEG2D Polyethylene glycols split dose Polyethylene Glycols	SPMC1D Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy Natrium picosulfate / Magnesium citrate	SPMC2D Natrium picosulfate/ Magnesium citrate split dose Natrium picosulfate / Magnesium citrate	PEGA1D Polyethylene glycol / Ascorbic acid single dose day before colonoscopy Polyethylene glycol / Ascorbic acid	PEGA2D Polyethylene glycol / Ascorbic acid split dose Polyethylene glycol / Ascorbic acid
Overall Study STARTED	174	174	174	174	174	174
Overall Study COMPLETED	160	162	166	159	169	157
Overall Study NOT COMPLETED	14	12	8	15	5	17

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG1D Polyethylene glycols single dose a day before colonoscopy Polyethylene Glycols	PEG2D Polyethylene glycols split dose Polyethylene Glycols	SPMC1D Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy Natrium picosulfate / Magnesium citrate	SPMC2D Natrium picosulfate/ Magnesium citrate split dose Natrium picosulfate / Magnesium citrate	PEGA1D Polyethylene glycol / Ascorbic acid single dose day before colonoscopy Polyethylene glycol / Ascorbic acid	PEGA2D Polyethylene glycol / Ascorbic acid split dose Polyethylene glycol / Ascorbic acid
Overall Study Discontinued intervention	14	10	7	14	4	17
Overall Study Lost to Follow-up	0	2	1	1	1	0

Baseline Characteristics

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG1D n=160 Participants Polyethylene glycols single dose a day before colonoscopy	PEG2D n=162 Participants Polyethylene glycols split dose	SPMC1D n=166 Participants Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	SPMC2D n=159 Participants Natrium picosulfate/ Magnesium citrate split dose	PEGA1D n=169 Participants Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	PEGA2D n=157 Participants Polyethylene glycol / Ascorbic acid split dose	Total n=973 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 15.3 • n=5 Participants	64.5 years STANDARD_DEVIATION 13.9 • n=7 Participants	60.8 years STANDARD_DEVIATION 16.1 • n=5 Participants	63.1 years STANDARD_DEVIATION 13.1 • n=4 Participants	60.1 years STANDARD_DEVIATION 14.3 • n=21 Participants	60.6 years STANDARD_DEVIATION 17.0 • n=10 Participants	62.1 years STANDARD_DEVIATION 14.2 • n=115 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	70 Participants n=7 Participants	81 Participants n=5 Participants	77 Participants n=4 Participants	67 Participants n=21 Participants	67 Participants n=10 Participants	429 Participants n=115 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	92 Participants n=7 Participants	85 Participants n=5 Participants	82 Participants n=4 Participants	102 Participants n=21 Participants	90 Participants n=10 Participants	544 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=5 Participants	162 Participants n=7 Participants	166 Participants n=5 Participants	159 Participants n=4 Participants	169 Participants n=21 Participants	157 Participants n=10 Participants	973 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Czechia	160 Participants n=5 Participants	162 Participants n=7 Participants	166 Participants n=5 Participants	159 Participants n=4 Participants	169 Participants n=21 Participants	157 Participants n=10 Participants	973 Participants n=115 Participants

PRIMARY outcome

Timeframe: One day

Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

Outcome measures

Outcome measures
Measure	PEG1D n=160 Participants Polyethylene glycols single dose a day before colonoscopy	PEG2D n=162 Participants Polyethylene glycols split dose	SPMC1D n=166 Participants Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	SPMC2D n=159 Participants Natrium picosulfate/ Magnesium citrate split dose	PEGA1D n=169 Participants Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	PEGA2D n=157 Participants Polyethylene glycol / Ascorbic acid split dose
Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)	110 Participants	145 Participants	100 Participants	134 Participants	121 Participants	55 Participants

SECONDARY outcome

Timeframe: One day

Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)