Bowel Preparation for Colonoscopy in the Elderly

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: Standard full-volume PEG; Drug: Split-dose full-volume PEG; Drug: Split-dose low-volume PEG

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Guri, Korea, Republic of
    • Hanyang University GURI Hospital
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 130-702
    • Kyung Hee University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others.	1 year
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	The 3-grade scale: optimal (100%), good (≥ 75%), and poor (< 75%)	1 year
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
Taste of recommended bowel preparation agent based on the 3-grade scale	The 3-grade scale: bad, neutral, and good	1 year

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Hanyang University; Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Gastrointest Endosc. 2013 Sep;78(3):559.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 8, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Colonoscopy; Polyethylene Glycols; Cathartics
• Other Study ID Numbers: 4LPEG-2LPEGA-Elderly-2014