Impact of SFV of Proximal Colon on ADR
Primary Purpose
Adenoma Detection Rate
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
second forward view
Sponsored by
About this trial
This is an interventional treatment trial for Adenoma Detection Rate
Eligibility Criteria
Inclusion Criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy -
Exclusion Criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, Boston Bowel Preparation Score (BBPS) <6 points. ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥Recovery of polyp specimens failed, and no histopathological data. ⑦Patients with coagulation dysfunction.
-
Sites / Locations
- Third People's Hospital of Jingdezhen CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard withdrawal colonoscopy
second forward view
Arm Description
Observation of conventional colonoscopy
second forward view examination of the proximal colon
Outcomes
Primary Outcome Measures
proximal colon adenoma detection rate
proportion of patients with proximal colon adenoma found in all colonoscopy patients
Secondary Outcome Measures
whole colon adenoma detection rate
proportion of patients with colonic adenoma found in all colonoscopy patients
Cecal insertion time
the time elapsed from introducing the colonoscope into the anus until intubation of the cecum
proximal colon withdrawal time
observation time of proximal colon in the absence of polyp removal
total withdrawal time
the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal
BBPS
Boston bowel preparation score
whole colon polyp detection rate
proportion of patients with colonic polyp found in all colonoscopy patients
proximal colon polyp detection rate
proportion of patients with proximal colon polyp found in all colonoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04963010
Brief Title
Impact of SFV of Proximal Colon on ADR
Official Title
Impact of Second Forward View Examination of the Proximal Colon on Adenoma Detection Rate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Anticipated)
Study Completion Date
June 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Xiaojia
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
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Detailed Description
Background:
Colonoscopy can reduce the incidence and mortality rates of colorectal cancer, and the reduction in distal colon cancer is more pronounced than proximal colon cancer. Compared with CRC found on screening, interphase CRC is more likely to occur in the proximal colon above the splenic flexure. Adenoma detection rate (ADR) is an important quality indicator of colonoscopy. Compared with ADR>20%,the incidence of interphase CRC is 10 times higher for endoscopists with ADR<20%. For every 1% increase in ADR, the risk of interphase CRC can be reduced by 3%, and fatal interphase CRC can be reduced by 5%. It is reported in the literature that the second forward view examination of the right colon (cecum, ascending colon, liver flexure) can significantly improve the right colon ADR, however, there is no report on the impact of second forward view examination of the proximal colon ADR (cecum, ascending colon, liver flexure, and transverse colon).
Objective:
To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria: Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:
①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores < 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction.
Methods:
Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.
Primary Outcome:
proximal colon adenoma detection rate:proportion of patients with proximal colon adenoma found in all colonoscopy patients Secondary Outcome whole colon adenoma detection rate:proportion of patients with colonic adenoma found in all colonoscopy patients Cecal insertion time: the time elapsed from introducing the colonoscope into the anus until intubation of the cecum.
proximal colon withdrawal time: observation time of proximal colon in the absence of polyp removal total withdrawal time:the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal BBPS:Boston bowel preparation score whole colon polyp detection rate:proportion of patients with colonic polyp found in all colonoscopy patients proximal colon polyp detection rate:proportion of patients with proximal colon polyp found in all colonoscopy
Research design Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform. Patients in the second forward view (SFV) group were inserted into the cecum again , colonoscope withdrawal to the splenic flexure, and the newly discovered polyps in the second forward view were also resection. Patients in the standard withdrawal colonoscopy withdraw the scope from the splenic flexure until exiting the anus,observe, if polyps are found, undergo endoscopic resection.
The assistant is responsible for recording the time.Cecal insertion time refers to the time elapsed from introducing the colonoscope into the anus until intubation of the cecum. Proximal colon withdrawal time refers to the observation time of proximal colon. And the total withdrawal time refers to the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal. Record BBPS, the number, location, size, Paris type and postoperative pathology of polyps.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Detection Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
910 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard withdrawal colonoscopy
Arm Type
No Intervention
Arm Description
Observation of conventional colonoscopy
Arm Title
second forward view
Arm Type
Experimental
Arm Description
second forward view examination of the proximal colon
Intervention Type
Diagnostic Test
Intervention Name(s)
second forward view
Intervention Description
second forward view examination of the proximal colon
Primary Outcome Measure Information:
Title
proximal colon adenoma detection rate
Description
proportion of patients with proximal colon adenoma found in all colonoscopy patients
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
whole colon adenoma detection rate
Description
proportion of patients with colonic adenoma found in all colonoscopy patients
Time Frame
up to 2 years
Title
Cecal insertion time
Description
the time elapsed from introducing the colonoscope into the anus until intubation of the cecum
Time Frame
up to 2 years
Title
proximal colon withdrawal time
Description
observation time of proximal colon in the absence of polyp removal
Time Frame
up to 2 years
Title
total withdrawal time
Description
the time measured from when the colonoscope reaches the cecum to the time the scope is withdrawn from the anus in the absence of polyp removal
Time Frame
up to 2 years
Title
BBPS
Description
Boston bowel preparation score
Time Frame
up to 2 years
Title
whole colon polyp detection rate
Description
proportion of patients with colonic polyp found in all colonoscopy patients
Time Frame
up to 2 years
Title
proximal colon polyp detection rate
Description
proportion of patients with proximal colon polyp found in all colonoscopy
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy -
Exclusion Criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, Boston Bowel Preparation Score (BBPS) <6 points. ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥Recovery of polyp specimens failed, and no histopathological data. ⑦Patients with coagulation dysfunction.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojia Zhu
Phone
15879497590
Email
zhuxiaojia2021@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang
Organizational Affiliation
Third People's Hospital of Jingdezhen City
Official's Role
Study Director
Facility Information:
Facility Name
Third People's Hospital of Jingdezhen City
City
Jingdezhen
State/Province
Jiangxi
ZIP/Postal Code
333000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Zhu
Email
zhuxiaojia2021@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing data after the research over
IPD Sharing Time Frame
Half a year after the research over and lasts for 2 years
IPD Sharing Access Criteria
Gastroenterologist
IPD Sharing URL
http://www.clinicaltrials.gov
Learn more about this trial
Impact of SFV of Proximal Colon on ADR
We'll reach out to this number within 24 hrs