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Bowel Preparation for Colonoscopy in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290093
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Kangbuk Samsung Hospital
Hanyang University
Information provided by (Responsible Party):
Chang Kyun Lee, Kyunghee University Medical Center

Brief Summary:

The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people.

The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume [2L] PEG-3350 containing ascorbic acid solution.


Condition or disease Intervention/treatment Phase
Bowel Preparation Colonoscopy Drug: Standard full-volume PEG Drug: Split-dose full-volume PEG Drug: Split-dose low-volume PEG Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Bowel Preparation With Standard 4 Liters of PEG vs. Split-dose of 4 Liters PEG vs. Split-dose of 2 Liters PEG Containing Ascorbic Acid Solutions for Outpatient Elective Colonoscopy in the Elderly: A Randomized, Colonoscopist-blinded Study
Study Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard full-volume PEG Drug: Standard full-volume PEG
Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.

Experimental: Split-dose full-volume PEG Drug: Split-dose full-volume PEG
Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.

Experimental: Split-dose low-volume PEG Drug: Split-dose low-volume PEG
Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.




Primary Outcome Measures :
  1. Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS). [ Time Frame: 1 year ]
    The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment.


Secondary Outcome Measures :
  1. Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale [ Time Frame: 1 year ]
  2. Rate of adverse events related to bowel preparation for colonoscopy [ Time Frame: 1 year ]
    Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others.

  3. Number of patients who have a willingness to repeat same bowel preparation method method [ Time Frame: 1 year ]
  4. Consumed volume of recommended bowel preparation agent based on the 3-grade scale [ Time Frame: 1 year ]
    The 3-grade scale: optimal (100%), good (≥ 75%), and poor (< 75%)

  5. Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale [ Time Frame: 1 year ]
    The 3-grade scale: never, some, and much

  6. Taste of recommended bowel preparation agent based on the 3-grade scale [ Time Frame: 1 year ]
    The 3-grade scale: bad, neutral, and good



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elderly people aged over 65 years
  • elective outpatient colonoscopy
  • informed consent

Exclusion Criteria:

  • patients who had bowel movements of less than 3 per week during last one month
  • patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance)
  • patients who have a history of alimentary tract surgery
  • patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis)
  • patients classified as the American Society for Anesthesiology class III or higher
  • Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290093


Locations
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Korea, Republic of
Hanyang University Guri Hospital
Guri, Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
Kangbuk Samsung Hospital
Hanyang University
Publications of Results:
Other Publications:
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Responsible Party: Chang Kyun Lee, Associate professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02290093    
Other Study ID Numbers: 4LPEG-2LPEGA-Elderly-2014
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by Chang Kyun Lee, Kyunghee University Medical Center:
Cathartics
Colonoscopy
Polyethylene Glycols
Elderly