Back to resultsThe Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
Primary Purpose
Polyp, Adenoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Colonoscopist only
Experienced Endoscopy Nurse Participation
Sponsored by
About this trial
This is an interventional treatment trial for Polyp focused on measuring Nurse; Colonoscopy; Polyp; Adenoma;
Eligibility Criteria
Inclusion Criteria:
- age 40-70 average risk screening colonoscopy
Exclusion Criteria:
- GI Bleeding ;
- history of colorectal surgery ;
- inflammatory bowel disease ;
- colorectal cancer,or polyposis syndrome
Sites / Locations
- Ningbo NO.1 hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
endoscopist only
nurse participation
Arm Description
Single inspection by endoscopist during colonoscopy
Dual inspection by both an endoscopist and an experienced nurse during colonoscopy
Outcomes
Primary Outcome Measures
Polyp detection rate
adenoma detection rate
Secondary Outcome Measures
Advanced polyp detection rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02292563
Brief Title
The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
Official Title
Can Experienced Endoscopy Nurse Participation During Screening Colonoscopy Increase Polyp and Adenoma Detection Rate?:A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp, Adenoma
Keywords
Nurse; Colonoscopy; Polyp; Adenoma;
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoscopist only
Arm Type
Experimental
Arm Description
Single inspection by endoscopist during colonoscopy
Arm Title
nurse participation
Arm Type
Experimental
Arm Description
Dual inspection by both an endoscopist and an experienced nurse during colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Colonoscopist only
Intervention Description
Only Colonosopist Observe during Colonoscopy (single observer)
Intervention Type
Procedure
Intervention Name(s)
Experienced Endoscopy Nurse Participation
Intervention Description
Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)
Primary Outcome Measure Information:
Title
Polyp detection rate
Time Frame
1.5 year
Title
adenoma detection rate
Time Frame
1.5 year
Secondary Outcome Measure Information:
Title
Advanced polyp detection rate
Time Frame
1.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 40-70 average risk screening colonoscopy
Exclusion Criteria:
GI Bleeding ;
history of colorectal surgery ;
inflammatory bowel disease ;
colorectal cancer,or polyposis syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIAOYUN DING, M.D
Organizational Affiliation
Ningbo No. 1 Hospital
Official's Role
Study Director
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
29541895
Citation
Wang W, Xu L, Bao Z, Sun L, Hu C, Zhou F, Xu L, Shi D. Differences with experienced nurse assistance during colonoscopy in detecting polyp and adenoma: a randomized clinical trial. Int J Colorectal Dis. 2018 May;33(5):561-566. doi: 10.1007/s00384-018-3003-0. Epub 2018 Mar 14.
Results Reference
derived
Learn more about this trial
The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
We'll reach out to this number within 24 hrs