NCT02290093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

October 31, 2014

Last Update Submit

February 22, 2016

Conditions

Bowel PreparationColonoscopy

Keywords

CatharticsColonoscopyPolyethylene GlycolsElderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • 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

  • Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale

    1 year

  • +1 more secondary outcomes

Study Arms (3)

Standard full-volume PEG

ACTIVE COMPARATOR
Drug: Standard full-volume PEG

Split-dose full-volume PEG

EXPERIMENTAL
Drug: Split-dose full-volume PEG

Split-dose low-volume PEG

EXPERIMENTAL
Drug: Split-dose low-volume PEG

Interventions

Standard full-volume PEGDRUG

Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.

Standard full-volume PEG
Split-dose full-volume PEGDRUG

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.

Split-dose full-volume PEG
Split-dose low-volume PEGDRUG

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.

Split-dose low-volume PEG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • elderly people aged over 65 years
  • elective outpatient colonoscopy
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Kyung Hee University Hospital

Seoul, 130-702, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 20579994BACKGROUND

  • 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.

    PMID: 23664042BACKGROUND

  • 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.

    PMID: 18190651RESULT

  • 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.

    PMID: 24645966RESULT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 13, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

KR(3)