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Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

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ClinicalTrials.gov Identifier: NCT03352700
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L 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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Scale the Amount of Air Bubble Adenoma Detection Rate Drug: 3L PEG Drug: 3L PEG+Dyclonine Hydrochloride Mucilage Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Placebo Comparator: 3L PEG
only used 3L PEG
Drug: 3L PEG
Group A patients (n = 300) used only 3L PEG before colonoscopy.

Experimental: 3L PEG+Dyclonine Hydrochloride Mucilage
used 3L PEG+Dyclonine Hydrochloride Mucilage
Drug: 3L PEG+Dyclonine Hydrochloride Mucilage
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG




Primary Outcome Measures :
  1. the amount of air bubbles [ Time Frame: 2 days ]
    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. Bubbles filling the entire lumen.


Secondary Outcome Measures :
  1. adenoma detection rate [ Time Frame: 2 days ]
    The secondary end point of the study included adenoma detection rate

  2. mean total adenomas detected beyond first [ Time Frame: 2 days ]
    It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients are between 18-75 years old
  2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352700


Contacts
Contact: Zhaosheng Li, MD +86-21-31161335 zhaoshenlismmu@gmail.com
Contact: Yu Bai +86-13564665324 baiyu1998@hotmail.com

Locations
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: Peng Cheng Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party: Zhaoshen Li, Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03352700     History of Changes
Other Study ID Numbers: Dyclonine-01
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Dyclonine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents