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Examining Techniques on Adenoma Miss Rate in Proximal Colon (SINOCOLO2017)

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ClinicalTrials.gov Identifier: NCT03355443
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
En-Da Yu, Changhai Hospital

Brief Summary:

The primary aim of this study is

- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.

Other aims include to explore the data below when re-examination or retroflexion is used.

  • Adenoma detection rate, ADR
  • Polyp miss rate, PMR
  • Polyp detection rate, PDR
  • Withdrawal time, WT

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Colorectal Polyp Procedure: Retroflexion Procedure: Re-examination Not Applicable

Detailed Description:
AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Re-examination Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method.
Procedure: Re-examination
Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.

Experimental: Retroflexion Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method.
Procedure: Retroflexion
Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.




Primary Outcome Measures :
  1. Adenoma miss rate in the proximal colon (AMR) [ Time Frame: At the end of the procedure, up to 1 hour ]
    AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.


Secondary Outcome Measures :
  1. Adenoma Detection Rate in the proximal colon (ADR) [ Time Frame: At the end of the procedure, up to 1 hour ]
    ADR refers to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. ADR in the proximal colon is calculated with only the proximal colon concerned.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result

Exclusion Criteria:

  • Pregnant female patients
  • Patients received colonoscopy in the past 5 years
  • Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
  • Patients who had previous abdominal surgery
  • Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
  • Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
  • Patients who have inadequate bowel preparation
  • Patients who reject to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355443


Contacts
Contact: En-Da YU, MBBS 08618699629177 endayu@yeah.net
Contact: Zi-Ye ZHAO, MD yemenzhao@126.com

Locations
China, Guangdong
the Sixth affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510655
Contact: Chu-Jun LI, MBBS    8602038777676      
China
Zhongshan Hospital affiliated to Fudan University Not yet recruiting
Shanghai, China, 200032
Contact: Ping-Hong ZHOU, MD         
Tianjin Renmin Hospital Not yet recruiting
Tianjin, China, 300121
Contact: Wen LI         
Sponsors and Collaborators
Changhai Hospital

Publications of Results:
Responsible Party: En-Da Yu, Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03355443     History of Changes
Other Study ID Numbers: SINOCOLO2017
2017YFC1308802 ( Other Grant/Funding Number: National Key R&D Program of China )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by En-Da Yu, Changhai Hospital:
Colonoscopy
Lower Gastrointestinal Tract
Re-examination
Retroflexion

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms