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Bowel PreparationPhase 4NCT02290093

Bowel Preparation for Colonoscopy in the Elderly

A Phase 4 study testing Standard full-volume PEG, Split-dose full-volume PEG and Split-dose low-volume PEG in people with Bowel Preparation and Colonoscopy, run by Kyunghee University Medical Center at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Bowel Preparation, Colonoscopy
What is being tested?
Standard full-volume PEG, Split-dose full-volume PEG and Split-dose low-volume PEG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
3 sitesSouth Korea
Study dates
Nov 2014to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Hanyang University Guri Hospital

    Guri-si

  • Kangbuk Samsung Hospital

    Seoul, 110-746

  • Kyung Hee University Hospital

    Seoul, 130-702

Other trials in South Korea

About this study

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.

Being tested
Standard full-volume PEG, Split-dose full-volume PEG, Split-dose low-volume PEG
Keywords
Cathartics, Colonoscopy, Polyethylene Glycols, Elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard full-volume PEGDrug

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

  • 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 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.

Study groups in NCT02290093
Study groupRoleWhat they receive
Standard full-volume PEGActive comparatorNot described
Receives: Drug: Standard full-volume PEG
Split-dose full-volume PEGExperimentalNot described
Receives: Drug: Split-dose full-volume PEG
Split-dose low-volume PEGExperimentalNot described
Receives: Drug: Split-dose low-volume PEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (6)

  1. Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. Number of patients who have a willingness to repeat same bowel preparation method method

    Measured: 1 year

  4. Consumed volume of recommended bowel preparation agent based on the 3-grade scale

    The 3-grade scale: optimal (100%), good (≥ 75%), and poor (< 75%)

    Measured: 1 year

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

    The 3-grade scale: never, some, and much

    Measured: 1 year

  6. Taste of recommended bowel preparation agent based on the 3-grade scale

    The 3-grade scale: bad, neutral, and good

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionSep 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290093
Sponsor's protocol ID
4LPEG-2LPEGA-Elderly-2014
Status last verified
Feb 2016
First submitted
31 Oct 2014
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20579994

  • 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.

    PubMed 23664042

  • 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.

    PubMed 18190651

  • 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.

    PubMed 24645966

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Standard full-volume PEG, Split-dose full-volume PEG and Split-dose low-volume PEG in people with Bowel Preparation and Colonoscopy, run by Kyunghee University Medical Center at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS). (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290093, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

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