Bowel Preparation for Colonoscopy in the Elderly
- Conditions
- Bowel PreparationColonoscopy
- Interventions
- Registration Number
- NCT02290093
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
- elderly people aged over 65 years
- elective outpatient colonoscopy
- informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard full-volume PEG Standard full-volume PEG - Split-dose low-volume PEG Split-dose low-volume PEG - Split-dose full-volume PEG Split-dose full-volume PEG -
- Primary Outcome Measures
Name Time Method Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS). 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
Name Time Method Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale 1 year The 3-grade scale: never, some, and much
Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale 1 year Rate of adverse events related to bowel preparation for colonoscopy 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 1 year Consumed volume of recommended bowel preparation agent based on the 3-grade scale 1 year The 3-grade scale: optimal (100%), good (≥ 75%), and poor (\< 75%)
Taste of recommended bowel preparation agent based on the 3-grade scale 1 year The 3-grade scale: bad, neutral, and good
Trial Locations
- Locations (3)
Hanyang University Guri Hospital
🇰🇷Guri, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of