Comparison of Two Methods of Administration of a PEG Solution
PEG
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is to compare the effectiveness (quality of bowel cleansing) and ease of use (patient satisfaction) of two methods of administration of a precolonoscopy PEG solution in hospitalized patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 colorectal-cancer
Started Mar 2009
Typical duration for phase_4 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 13, 2016
April 1, 2016
2.8 years
February 20, 2008
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cleanliness of the bowel, as determined by the examiner, and ease of use, as determined by a patient satisfaction questionnaire in the two study arms
1 year
Secondary Outcomes (1)
Effect of external factors (demographic parameters, length of hospitalization, procedural diagnosis) on the quality of the bowel preparation
1 year
Study Arms (2)
1
ACTIVE COMPARATORGroup 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
2
ACTIVE COMPARATORGroup 2 will receive half the dose (1.5 liters) of the identical solution in the evening preceding the test and the other half (1.5 liters) on the morning of the test.
Interventions
Group 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
PEG solution: half the dose (1.5 liters) of the identical solution in the evening preceding the test and the other half (1.5 liters) on the morning of the test
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- ability to understand and complete the questionnaires
- ability to participate in all stages of the research
You may not qualify if:
- Previous colon surgery
- endoscopic procedures under full anesthesia
- known sensitivity to the PEG solution
- terminal renal or cardiac insufficiency
- inability to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yaron Niv, Prof
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterology Institute Deputy-manager
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
March 1, 2009
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
April 13, 2016
Record last verified: 2016-04