Colonoscopy Clinical Trial
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
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.
Status | Completed |
Enrollment | 230 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hanyang University Guri Hospital | Guri | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Kyung Hee University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University Medical Center | Hanyang University, Kangbuk Samsung Hospital |
Korea, Republic of,
ASGE Standards of Practice Committee, Chandrasekhara V, Early DS, Acosta RD, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Foley KQ, Fonkalsrud L, Hwang JH, Jue T, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Shergill AK, Cash BD. Modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2013 Jul;78(1):1-7. doi: 10.1016/j.gie.2013.04.161. Epub 2013 May 9. Review. Erratum in: Gastrointest Endosc. 2013 Sep;78(3):559. — View Citation
Cohen LB. Split dosing of bowel preparations for colonoscopy: an analysis of its efficacy, safety, and tolerability. Gastrointest Endosc. 2010 Aug;72(2):406-12. doi: 10.1016/j.gie.2010.04.001. Epub 2010 Jul 1. Review. — View Citation
Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Rünzi M, Schneider T, Kachel G, Grüger J, Köllinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing be — View Citation
Téllez-Ávila FI, Murcio-Pérez E, Saúl A, Herrera-Gómez S, Valdovinos-Andraca F, Acosta-Nava V, Barreto R, Elizondo-Rivera J. Efficacy and tolerability of low-volume (2 L) versus single- (4 L) versus split-dose (2 L + 2 L) polyethylene glycol bowel prepara — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS). | 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. | 1 year | No |
Secondary | Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale | 1 year | No | |
Secondary | Rate of adverse events related to bowel preparation for colonoscopy | Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others. | 1 year | Yes |
Secondary | Number of patients who have a willingness to repeat same bowel preparation method method | 1 year | No | |
Secondary | Consumed volume of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: optimal (100%), good (= 75%), and poor (< 75%) | 1 year | No |
Secondary | Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: never, some, and much | 1 year | No |
Secondary | Taste of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: bad, neutral, and good | 1 year | No |
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