NCT02540239

Brief Summary

To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S) for colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

March 2, 2015

Last Update Submit

April 18, 2016

Conditions

Bowel Preparation Scalethe Amount of Air BubbleAdenoma Detection Rate

Outcome Measures

Primary Outcomes (3)

  • adenoma detection rate

    2 days

  • bowel preparation scale

    2 days

  • the amount of air bubbles

    Five areas of the colon (rectosigmoid, descending, transverse, ascending, and cecum) were graded for the amount of air bubbles.The amount of intraluminal air bubbles was classified into four grades as shown below: Grade 0 = No or minimal scattered bubbles; Grade 1 = Bubbles covering at least half the luminal diameter; Grade 2 = Bubbles covering the circumference of the lumen; Grade 3 = Bubbles filling the entire lumen.

    2 days

Study Arms (2)

2L PEG

PLACEBO COMPARATOR

only used 2L PEG

Drug: 2L PEG

Simethione+2L PEG

EXPERIMENTAL

used 2L PEG+Simethione

Drug: 2L PEG+simethicone

Interventions

2L PEGDRUG
2L PEG
2L PEG+simethiconeDRUG
Simethione+2L PEG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are between 18-65 years old
  • undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

You may not qualify if:

  • suspected gastrointestinal obstruction or perforation
  • severe acute inflammatory bowel disease
  • toxic megacolon
  • ileus or gastric retention, ileostomy,
  • hypersensitivity to any of the ingredients
  • pregnancy and lactation and/or at a risk of becoming pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • Di Nardo G, Aloi M, Cucchiara S, Spada C, Hassan C, Civitelli F, Nuti F, Ziparo C, Pession A, Lima M, La Torre G, Oliva S. Bowel preparations for colonoscopy: an RCT. Pediatrics. 2014 Aug;134(2):249-56. doi: 10.1542/peds.2014-0131. Epub 2014 Jul 7.

    PMID: 25002661BACKGROUND

  • Gentile M, De Rosa M, Cestaro G, Forestieri P. 2 L PEG plus ascorbic acid versus 4 L PEG plus simethicon for colonoscopy preparation: a randomized single-blind clinical trial. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):276-80. doi: 10.1097/SLE.0b013e31828e389d.

    PMID: 23751992BACKGROUND

  • Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.

    PMID: 28985630DERIVED

Study Officials

  • LI ZHAO SHEN, M.D

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive Endoscopy Center

Study Record Dates

First Submitted

March 2, 2015

First Posted

September 3, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CN(1)