Impacts of Inspection During Instrument Insertion on Colonoscopy Quality
1 other identifier
interventional
428
1 country
1
Brief Summary
Small colon polyps which are found during colonoscopy insertion are sometimes difficult to find during withdrawal and thus missed. The investigators aim to evaluate the differences of colon polyp/adenoma detection rates of patients undergoing additional inspection and polypectomy during insertion as compared to the patients undergoing traditional practice of careful inspection and polypectomy performed entirely during withdrawal of colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2017
CompletedFirst Submitted
Initial submission to the registry
February 10, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
May 9, 2019
CompletedMay 9, 2019
February 1, 2019
9 months
February 10, 2018
September 22, 2018
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
During procedure, approximately one hour
Secondary Outcomes (1)
Mean Colon Adenoma Per Colonoscopy
During procedure, approximately one hour
Study Arms (2)
Insertion/withdrawal colon polypectomy
EXPERIMENTALFor participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size \<10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size \>10 mm will be performed only during withdrawal of the scope.
Withdrawal colon polypectomy
ACTIVE COMPARATORFor participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Interventions
For participants assigned into the experimental group, colon lumen is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both the insertion and withdrawal phases. Colon polyps with size \<10 mm are removed as they are identified on insertion and withdrawal. Polyps with size \>10 mm are removed only during withdrawal. For participants assigned into the control group, deliberate inspection and polyp removal are performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
Eligibility Criteria
You may qualify if:
- Aged 45 years or older.
- Agree to participate the study and provide a written informed consent
You may not qualify if:
- Previous surgical resection of the colon or rectum
- Inflammatory bowel disease
- Polyposis syndrome
- Previously incomplete colonoscopy
- Obstructive lesions of colon
- Inadequate bowel preparation, defined as Boston Bowel Preparation Scale score of 0 or 1 in any colon segment
- Gastrointestinal bleeding
- Allergy to fentanyl or midazolam
- American Society of Anesthesiology classification of physical status 3 or higher
- Mental retardation
- Pregnancy
- Refusal to provide a written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evergreen General Hospital
Taoyuan District, 320, Taiwan
Related Publications (1)
Cheng CL, Kuo YL, Liu NJ, Tang JH, Fan JW, Lin CH, Tsui YN, Lee BP, Hung HL. Comparison of polyp detection during both insertion and withdrawal versus only withdrawal of colonoscopy: A prospective randomized trial. J Gastroenterol Hepatol. 2019 Aug;34(8):1377-1383. doi: 10.1111/jgh.14613. Epub 2019 Feb 27.
PMID: 30675926DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Chi-Liang Cheng
- Organization
- Evergreen General Hospital, Taoyuan, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Chiliang Cheng
Evergreen General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology
Study Record Dates
First Submitted
February 10, 2018
First Posted
February 23, 2018
Study Start
October 2, 2017
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
May 9, 2019
Results First Posted
May 9, 2019
Record last verified: 2019-02