Clinical trial NCT02540239: Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation Scale
the Amount of Air Bubble
Adenoma Detection Rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Sir Run Run Shaw Hospital
name: Tongji Hospital
name: Qilu Hospital of Shandong University
name: Zhongda Hospital
name: Jinan Military General Hospital
name: First Hospital of China Medical University
First posted: 2015-09-03
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: adenoma detection rate
timeFrame: 2 days
measure: bowel preparation scale
timeFrame: 2 days
measure: the amount of air bubbles
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: LI ZHAO SHEN, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.