Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

NCT02581475 | Completed Results DMC

• 1 other identifier: 2015SDU-QILU-G12
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).

Conditions

Colonic Polyps

Keywords

Adenoma detection rate; Colonoscopy; Withdrawal time

Outcome Measures

Primary Outcomes (1)

• Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.

  Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.

  During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.

Secondary Outcomes (3)

• Withdrawal Time in the Proximal Colon Among 2 Group.

  During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.

• Duration of the Total Colonoscopy Among 2 Group.

  During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.

• Adenomas Per Patient in the Proximal Colon Among 2 Group.

  During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Extending withdrawal time in the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy. From cecum to hepatic flexure, 1.5-2 min is required and 2.5-3 min is required from heptic flexure to splenic flexure.

Procedure: Extending withdrawal time in the proximal colon

Group B

EXPERIMENTAL

Segmental examination twice of the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure. The withdrawal time in each colonic segment is similar to the group A.

Procedure: Segmental examination twice of the proximal colon

Interventions

Extending withdrawal time in the proximal colon PROCEDURE

Group A

Segmental examination twice of the proximal colon PROCEDURE

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asia-Pacific Colorectal Screening score ≥2, such as patients ≥ 50 years, patients with a family history of colorectal cancer in a first-degree relative or male patients with current or past smoking.

You may not qualify if:

• Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
• The cecum could not be intubated.
• Inadequate bowel preparation (Boston Bowel Preparation Scale score \<2 in any segment of the colon).
• Biopsies were not available.
• Unable to provide informed consent.

Sponsors & Collaborators

• Yanqing Li: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (4)

• Martinez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9.

  PMID: 19171141 BACKGROUND

• Butterly L, Robinson CM, Anderson JC, Weiss JE, Goodrich M, Onega TL, Amos CI, Beach ML. Serrated and adenomatous polyp detection increases with longer withdrawal time: results from the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2014 Mar;109(3):417-26. doi: 10.1038/ajg.2013.442. Epub 2014 Jan 7.

  PMID: 24394752 BACKGROUND

• Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.

  PMID: 18389446 BACKGROUND

• Guo CG, Zhang F, Ji R, Li Y, Li L, Zuo XL, Li YQ. Efficacy of segmental re-examination of proximal colon for adenoma detection during colonoscopy: a randomized controlled trial. Endoscopy. 2017 Mar;49(3):243-250. doi: 10.1055/s-0042-122013. Epub 2017 Jan 27.

  PMID: 28129661 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Yanqing Li
• Organization: Shandong University Qilu Hospital

liyanqing@sdu.edu.cn

+86-531-82169236

Study Officials

• Yanqing Li, PhD, MD

  Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 19, 2016
• Results First Posted: October 19, 2016

Record last verified: 2016-08

Locations

CN (1)