Impact of SFV of Proximal Colon on ADR

Impact of Second Forward View Examination of the Proximal Colon on Adenoma Detection Rate

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.

Study Overview

• Status: Recruiting
• Conditions: Adenoma Detection Rate
• Intervention / Treatment: Diagnostic test: second forward view

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.

• Study Type: Interventional
• Enrollment (Anticipated): 910
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Jingdezhen, Jiangxi, China, 333000
      • Recruiting
      • Third People's Hospital of Jingdezhen City
      • Contact: Xiaojia Zhu; Email: zhuxiaojia2021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard withdrawal colonoscopy; Observation of conventional colonoscopy
Experimental: second forward view; second forward view examination of the proximal colon	Diagnostic test: second forward view; second forward view examination of the proximal colon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proximal colon adenoma detection rate	proportion of patients with proximal colon adenoma found in all colonoscopy patients	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
whole colon adenoma detection rate	proportion of patients with colonic adenoma found in all colonoscopy patients	up to 2 years
Cecal insertion time	the time elapsed from introducing the colonoscope into the anus until intubation of the cecum	up to 2 years
proximal colon withdrawal time	observation time of proximal colon in the absence of polyp removal	up to 2 years
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
BBPS	Boston bowel preparation score	up to 2 years
whole colon polyp detection rate	proportion of patients with colonic polyp found in all colonoscopy patients	up to 2 years
proximal colon polyp detection rate	proportion of patients with proximal colon polyp found in all colonoscopy	up to 2 years

Collaborators and Investigators

• Sponsor: Zhu Xiaojia
• Investigators: Study Director: Li Yang, Third People's Hospital of Jingdezhen City

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Anticipated): June 8, 2022
• Study Completion (Anticipated): June 8, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: ThirdPeoplesHJingdezhenCity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No