Second Forward View Examination of Proximal Colon on Adenoma Detection Rate

NCT03619122 | Completed

• 1 other identifier: 2018-R014
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.

Conditions

Colon Adenoma

Outcome Measures

Primary Outcomes (1)

• per-patient detection rate of adenoma of proximal colon

  the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy

  1 day

Study Arms (2)

Second Examination

EXPERIMENTAL

Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination.

Procedure: Second Examination

Traditional Examinaiton

NO INTERVENTION

Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly.

Interventions

Second Examination PROCEDURE

The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.

Second Examination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing colonoscopy for screening in our hospital

You may not qualify if:

• previous history of resection of colon;
• familial polyposis syndrome
• inflammatory bowel disease
• active antiplatelet or anticoagulant therapy prevent polypectomy;
• pregnancy or lactating women

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (1)

• Shan K, Lu H, Zhang Z, Xie J, Xu L, Wang W, Hu C, Xu L. Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2021 May 10;21(1):213. doi: 10.1186/s12876-021-01783-9.

  PMID: 33971824 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: September 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

CN (1)