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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.
- 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.
- 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.
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
|the Sixth affiliated Hospital of Sun Yat-Sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510655|
|Contact: Chu-Jun LI, MBBS 8602038777676|
|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|