Clinical trial NCT02290093: Bowel Preparation for Colonoscopy in the Elderly
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation
Colonoscopy
Keywords: Cathartics
Colonoscopy
Polyethylene Glycols
Elderly
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kangbuk Samsung Hospital
name: Hanyang University
First posted: 2014-11-13
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS).
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale
timeFrame: 1 year
measure: Rate of adverse events related to bowel preparation for colonoscopy
timeFrame: 1 year
measure: Number of patients who have a willingness to repeat same bowel preparation method method
timeFrame: 1 year
measure: Consumed volume of recommended bowel preparation agent based on the 3-grade scale
timeFrame: 1 year
measure: Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale
timeFrame: 1 year
measure: Taste of recommended bowel preparation agent based on the 3-grade scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
References:
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. No abstract available.
citation: 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. No abstract available.
citation: Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.
citation: Tellez-Avila FI, Murcio-Perez E, Saul A, Herrera-Gomez 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 preparation for colonoscopy: randomized clinical trial. Dig Endosc. 2014 Nov;26(6):731-6. doi: 10.1111/den.12265. Epub 2014 Mar 20.