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Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

Primary Purpose

Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2L PEG
2L PEG+simethicone
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bowel Preparation Scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2L PEG

Simethione+2L PEG

Arm Description

only used 2L PEG

used 2L PEG+Simethione

Outcomes

Primary Outcome Measures

adenoma detection rate
bowel preparation scale
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2015
Last Updated
April 18, 2016
Sponsor
Changhai Hospital
Collaborators
First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Tongji Hospital, Qilu Hospital of Shandong University, Zhongda Hospital, Jinan Military General Hospital, First Hospital of China Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02540239
Brief Title
Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Tongji Hospital, Qilu Hospital of Shandong University, Zhongda Hospital, Jinan Military General Hospital, First Hospital of China Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S) for colonoscopy.
Detailed Description
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 2 L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to simeticone plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation Scale, the Amount of Air Bubble, Adenoma Detection Rate

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2L PEG
Arm Type
Placebo Comparator
Arm Description
only used 2L PEG
Arm Title
Simethione+2L PEG
Arm Type
Experimental
Arm Description
used 2L PEG+Simethione
Intervention Type
Drug
Intervention Name(s)
2L PEG
Intervention Type
Drug
Intervention Name(s)
2L PEG+simethicone
Primary Outcome Measure Information:
Title
adenoma detection rate
Time Frame
2 days
Title
bowel preparation scale
Time Frame
2 days
Title
the amount of air bubbles
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients are between 18-65 years old undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LI ZHAO SHEN, M.D
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25002661
Citation
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.
Results Reference
background
PubMed Identifier
23751992
Citation
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.
Results Reference
background
PubMed Identifier
28985630
Citation
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.
Results Reference
derived

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Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

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