Bowel Preparation for Colonoscopy in the Elderly
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|ClinicalTrials.gov Identifier: NCT02290093|
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : February 24, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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.
- 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.
- Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale [ Time Frame: 1 year ]
- 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.
- Number of patients who have a willingness to repeat same bowel preparation method method [ Time Frame: 1 year ]
- 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%)
- 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
- Taste of recommended bowel preparation agent based on the 3-grade scale [ Time Frame: 1 year ]The 3-grade scale: bad, neutral, and good
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
|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|