Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

• Sponsor: Tomas Bata Hospital, Czech Republic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02956057
• Collaborator: Brno University Hospital (Other), Faculty Hospital Kralovske Vinohrady (Other)
• Enrollment: 1,044
• Location: 1
• Arms: 6
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 114.3

Study Details

Study Description

Brief Summary

Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: Polyethylene Glycols; Drug: Natrium picosulfate / Magnesium citrate; Drug: Polyethylene glycol / Ascorbic acid	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1044 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy
• Actual Study Start Date: Nov 12, 2016
• Actual Primary Completion Date: May 29, 2017
• Actual Study Completion Date: Aug 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PEG1D Polyethylene glycols single dose a day before colonoscopy	Drug: Polyethylene Glycols
Active Comparator: PEG2D Polyethylene glycols split dose	Drug: Polyethylene Glycols
Active Comparator: SPMC1D Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	Drug: Natrium picosulfate / Magnesium citrate
Active Comparator: SPMC2D Natrium picosulfate/ Magnesium citrate split dose	Drug: Natrium picosulfate / Magnesium citrate
Active Comparator: PEGA1D Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	Drug: Polyethylene glycol / Ascorbic acid
Active Comparator: PEGA2D Polyethylene glycol / Ascorbic acid split dose	Drug: Polyethylene glycol / Ascorbic acid

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty Hospital Kralovske Vinohrady	Prague		Czechia	10024

Sponsors and Collaborators

• Tomas Bata Hospital, Czech Republic
• Brno University Hospital
• Faculty Hospital Kralovske Vinohrady

Investigators

• Principal Investigator: Vladimir Kojecky, MD, Nemocnice T.Bati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 3, 2016

More Information

Publications

• 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.

• Responsible Party: Vladimir Kojecky, MD, Ph.D., MUDr., Tomas Bata Hospital, Czech Republic
• ClinicalTrials.gov Identifier: NCT02956057
• Other Study ID Numbers: BN102016
• First Posted: Nov 4, 2016
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Ascorbic Acid; Magnesium citrate; Picosulfate sodium

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	PEG1D	PEG2D	SPMC1D	SPMC2D	PEGA1D	PEGA2D	Total
Arm/Group Description	Polyethylene glycols single dose a day before colonoscopy	Polyethylene glycols split dose	Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	Natrium picosulfate/ Magnesium citrate split dose	Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	Polyethylene glycol / Ascorbic acid split dose	Total of all reporting groups
Overall Participants	160	162	166	159	169	157	973
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (15.3)	64.5 (13.9)	60.8 (16.1)	63.1 (13.1)	60.1 (14.3)	60.6 (17.0)	62.1 (14.2)
Sex: Female, Male (Count of Participants)
Female	67 41.9%	70 43.2%	81 48.8%	77 48.4%	67 39.6%	67 42.7%	429 44.1%
Male	93 58.1%	92 56.8%	85 51.2%	82 51.6%	102 60.4%	90 57.3%	544 55.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	160 100%	162 100%	166 100%	159 100%	169 100%	157 100%	973 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Czechia	160 100%	162 100%	166 100%	159 100%	169 100%	157 100%	973 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
Description	Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)
Time Frame	One day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PEG1D	PEG2D	SPMC1D	SPMC2D	PEGA1D	PEGA2D
Arm/Group Description	Polyethylene glycols single dose a day before colonoscopy	Polyethylene glycols split dose	Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	Natrium picosulfate/ Magnesium citrate split dose	Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	Polyethylene glycol / Ascorbic acid split dose
Measure Participants	160	162	166	159	169	157
Count of Participants [Participants]	110 68.8%	145 89.5%	100 60.2%	134 84.3%	121 71.6%	55 35%

2. Secondary Outcome

Title	Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
Description	Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)
Time Frame	One day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PEG1D	PEG2D	SPMC1D	SPMC2D	PEGA1D	PEGA2D
Arm/Group Description	Polyethylene glycols single dose a day before colonoscopy	Polyethylene glycols split dose	Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy	Natrium picosulfate/ Magnesium citrate split dose	Polyethylene glycol / Ascorbic acid single dose day before colonoscopy	Polyethylene glycol / Ascorbic acid split dose
Measure Participants	160	162	166	159	169	157
Count of Participants [Participants]	56 35%	72 44.4%	134 80.7%	139 87.4%	85 50.3%	80 51%

Adverse Events

Time Frame	0
Adverse Event Reporting Description	AE not assessed
Arm/Group Title	PEG1D		PEG2D		SPMC1D		SPMC2D		PEGA1D		PEGA2D
Arm/Group Description	Polyethylene glycols single dose a day before colonoscopy		Polyethylene glycols split dose		Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy		Natrium picosulfate/ Magnesium citrate split dose		Polyethylene glycol / Ascorbic acid single dose day before colonoscopy		Polyethylene glycol / Ascorbic acid split dose
All Cause Mortality
	PEG1D		PEG2D		SPMC1D		SPMC2D		PEGA1D		PEGA2D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	PEG1D		PEG2D		SPMC1D		SPMC2D		PEGA1D		PEGA2D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	PEG1D		PEG2D		SPMC1D		SPMC2D		PEGA1D		PEGA2D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.