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Comparison of Two Methods of Administration of a PEG Solution

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00626054
First received: February 20, 2008
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: PEG solution in a single dose of 3 liters
Drug: PEG solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Administration of a PEG Solution During Bowel Preparation for Colonoscopy in Hospitalized Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of external factors (demographic parameters, length of hospitalization, procedural diagnosis) on the quality of the bowel preparation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
 Drug: PEG solution in a single dose of 3 liters
Group 1 will receive the precolonoscopy PEG solution in a single dose of 3 liters in the evening preceding the test.
Other Name: Meroken New
Active Comparator: 2
Group 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.
 Drug: PEG solution
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
Other Name: Meroken New

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years
  • ability to understand and complete the questionnaires
  • ability to participate in all stages of the research

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626054

Contacts
Contact: Ram M Dickman, MD 03-9377236 dickmanr@clalit.org.il
Contact: Yaron Niv, Prof 03-9377242 ext 7040 yniv@clalit.org.il

Locations
Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Ram Dickman, MD            
Principal Investigator: Ram Dickman, MD            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Yaron Niv, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: Dickman Ram/MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00626054     History of Changes
Other Study ID Numbers: 004907
Study First Received: February 20, 2008
Last Updated: July 22, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Colonoscopy
PEG Solution

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013