Back to resultsSecond Forward View Examination of Proximal Colon on Adenoma Detection Rate
Primary Purpose
Colon Adenoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Second Examination
Sponsored by
About this trial
This is an interventional screening trial for Colon Adenoma
Eligibility Criteria
Inclusion Criteria:
- all patients undergoing colonoscopy for screening in our hospital
Exclusion Criteria:
- previous history of resection of colon;
- familial polyposis syndrome
- inflammatory bowel disease
- active antiplatelet or anticoagulant therapy prevent polypectomy;
- pregnancy or lactating women
Sites / Locations
- Ningbo NO.1 hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Second Examination
Traditional Examinaiton
Arm Description
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination.
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly.
Outcomes
Primary Outcome Measures
per-patient detection rate of adenoma of proximal colon
the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03619122
Brief Title
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
Official Title
Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Second Examination
Arm Type
Experimental
Arm Description
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination.
Arm Title
Traditional Examinaiton
Arm Type
No Intervention
Arm Description
Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly.
Intervention Type
Procedure
Intervention Name(s)
Second Examination
Intervention Description
The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.
Primary Outcome Measure Information:
Title
per-patient detection rate of adenoma of proximal colon
Description
the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients undergoing colonoscopy for screening in our hospital
Exclusion Criteria:
previous history of resection of colon;
familial polyposis syndrome
inflammatory bowel disease
active antiplatelet or anticoagulant therapy prevent polypectomy;
pregnancy or lactating women
Facility Information:
Facility Name
Ningbo NO.1 hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33971824
Citation
Shan K, Lu H, Zhang Z, Xie J, Xu L, Wang W, Hu C, Xu L. Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2021 May 10;21(1):213. doi: 10.1186/s12876-021-01783-9.
Results Reference
derived
Learn more about this trial
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
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