Impact of SFV of Proximal Colon on ADR

Sponsor
Zhu Xiaojia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04963010
Collaborator
(none)
910
1
2
11.8
77.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: second forward view
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
910 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Second Forward View Examination of the Proximal Colon on Adenoma Detection Rate
Actual Study Start Date :
Jun 14, 2021
Anticipated Primary Completion Date :
Jun 8, 2022
Anticipated Study Completion Date :
Jun 8, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. proximal colon adenoma detection rate [up to 2 years]

    proportion of patients with proximal colon adenoma found in all colonoscopy patients

Secondary Outcome Measures

  1. whole colon adenoma detection rate [up to 2 years]

    proportion of patients with colonic adenoma found in all colonoscopy patients

  2. Cecal insertion time [up to 2 years]

    the time elapsed from introducing the colonoscope into the anus until intubation of the cecum

  3. proximal colon withdrawal time [up to 2 years]

    observation time of proximal colon in the absence of polyp removal

  4. total withdrawal time [up to 2 years]

    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

  5. BBPS [up to 2 years]

    Boston bowel preparation score

  6. whole colon polyp detection rate [up to 2 years]

    proportion of patients with colonic polyp found in all colonoscopy patients

  7. proximal colon polyp detection rate [up to 2 years]

    proportion of patients with proximal colon polyp found in all colonoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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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Contacts and Locations

Locations

Site City State Country Postal Code
1 Third People's Hospital of Jingdezhen City Jingdezhen Jiangxi China 333000

Sponsors and Collaborators

  • Zhu Xiaojia

Investigators

  • Study Director: Li Yang, Third People's Hospital of Jingdezhen City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhu Xiaojia, Attending physician, Third People's Hospital of Jingdezhen City
ClinicalTrials.gov Identifier:
NCT04963010
Other Study ID Numbers:
  • ThirdPeoplesHJingdezhenCity
First Posted:
Jul 15, 2021
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022