Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

Adenoma Detection Rate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540239
• Other study ID #: simethione
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: April 18, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• 2L PEG

• 2L PEG+simethicone

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Changhai Hospital	First Affiliated Hospital of Zhejiang University, First Hospital of China Medical University, Jinan Military General Hospital, Qilu Hospital, Sir Run Run Shaw Hospital, Tongji Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate		2 days	No
Primary	bowel preparation scale		2 days	No
Primary	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	No