Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04963010
Other study ID # ThirdPeoplesHJingdezhenCity
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 14, 2021
Est. completion date June 8, 2022

Study information

Verified date June 2022
Source Third People's Hospital of Jingdezhen City
Contact Xiaojia Zhu
Phone 15879497590
Email zhuxiaojia2021@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 910
Est. completion date June 8, 2022
Est. primary completion date June 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:Patients =18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy - Exclusion Criteria:?Cecal intubation failed. ?Have a history of colorectal surgery. ?Insufficient bowel preparation, Boston Bowel Preparation Score (BBPS) <6 points. ?Inflammatory bowel disease or intestinal tuberculosis. ?Familial polyp syndrome. ?Recovery of polyp specimens failed, and no histopathological data. ?Patients with coagulation dysfunction. -

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
second forward view
second forward view examination of the proximal colon

Locations

Country Name City State
China Third People's Hospital of Jingdezhen City Jingdezhen Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Zhu Xiaojia

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary proximal colon adenoma detection rate proportion of patients with proximal colon adenoma found in all colonoscopy patients up to 2 years
Secondary whole colon adenoma detection rate proportion of patients with colonic adenoma found in all colonoscopy patients up to 2 years
Secondary Cecal insertion time the time elapsed from introducing the colonoscope into the anus until intubation of the cecum up to 2 years
Secondary proximal colon withdrawal time observation time of proximal colon in the absence of polyp removal up to 2 years
Secondary 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 up to 2 years
Secondary BBPS Boston bowel preparation score up to 2 years
Secondary whole colon polyp detection rate proportion of patients with colonic polyp found in all colonoscopy patients up to 2 years
Secondary proximal colon polyp detection rate proportion of patients with proximal colon polyp found in all colonoscopy up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT03442738 - A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)
Completed NCT03041532 - Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme N/A
Not yet recruiting NCT05141773 - Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection N/A
Completed NCT03137277 - A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
Recruiting NCT05125939 - Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
Completed NCT04945044 - Artificial Intelligence Aid Systems in Colorectal Adenoma Detection N/A
Recruiting NCT05863208 - Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision N/A
Completed NCT04472741 - Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice N/A
Completed NCT04086706 - Retroflexion In The Ascending Colon Is A Costless Endoscopic Maneuver Increasing Adenoma Detection Rate
Not yet recruiting NCT03185299 - Impact of Reinforced Education by Video on the Quality of Bowel Preparation N/A
Completed NCT02507037 - Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy Phase 4
Completed NCT02540239 - Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy N/A
Completed NCT04397120 - The Factors Affecting ADR of Screening Colonoscopy
Completed NCT01786213 - Training Effects in Colonoscopy N/A
Completed NCT06173297 - Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.
Not yet recruiting NCT03356015 - Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation Phase 4
Not yet recruiting NCT03352700 - Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy Phase 4
Recruiting NCT04102631 - A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy N/A
Not yet recruiting NCT02832869 - Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation Phase 4