CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 650 enrolled
Drug / intervention
secondary colonoscopy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06186778
NCT06186778N/ACompleted

The Impact of Repeated Colonoscopic Insert Method on the Detection Rate of Adenomas in the Sigmoid Colon

Jianning Yao·interventional·Posted Jan 2, 2024·Updated Jun 10, 2024

In Brief

A clinical study evaluating secondary colonoscopy and conventional colonoscopy for Colorectal Polyp. Completed, enrolled 650 participants across 1 site.

Detailed Summary

Colorectal cancer (CRC) is a malignant tumour originating from the colorectal mucosal epithelium, with rising incidence and mortality rates. Approximately 90% of CRC develops from colorectal polyps, which are considered precancerous lesions of CRC, especially adenomatous polyps. If removed endoscopically during the polyp stage, 70%-90% of CRC can be prevented. However, current colonoscopy examinations have a high miss rate for polyps. Studies have shown that the miss rates for polyps and adenomas after colonoscopy can reach 22%-28% and 12%-26%, respectively. The "2014 Chinese Guidelines for Early Screening and Endoscopic Diagnosis and Treatment of Colorectal Cancer" mentions that the observation method during colonoscopy starts from the rectum and progresses forward to the cecum, with observations made during withdrawal. However, in actual clinical practice, it is found that single withdrawal observation is not enough, as this examination approach is prone to many missed polyps. The likely reason is that the colon is in a compressed state during withdrawal observation. Single-operator colonoscopy is currently the mainstream insertion method internationally, and the essence of the single-operator technique is "short-axis reductions", meaning that the colonoscope maintains a straight configuration throughout the entire examination. The average adult colon length is about 1.5m, but the distance reached by the colonoscope during the single-operator technique is often between 70-80cm, indicating compression of the colon. In addition, colonic folds become more dense when compressed, making it easier for lesions like polyps to hide within or near folds, leading to misses. The sigmoid colon, with the most turns in the entire large intestine, is also the part most prone to compression during colonoscopy insertion. Correspondingly, it is also more prone to misses during withdrawal observation. Although some scholars proposed repeating withdrawal to improve lesion detection rates, whether it is performed twice or three times, only compressed colons are observed. In actual clinical work, many polyps can only be found during insertion. The investigators propose performing a second insert specifically for the easily compressed sigmoid colon. During the second insert, the "short-axis reduction" technique should not be used. Instead, the folds should be deliberately advanced into, which helps fully extend the compressed sigmoid colon to shallow or eliminate the folds, allowing observation during advancement to achieve effects beyond multiple withdrawals, finding hidden lesions within or near folds to improve colonoscopy quality. Therefore, to explore whether observing during a second sigmoid colon advancement can further improve the adenoma detection rate to improve colonoscopy quality and reduce interval cancers, the investigators conducted this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJan 2, 2024
Enrollment StartJan 1, 2024
Primary CompletionApr 30, 2024
Study CompletionMay 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.5 years ago

Interventions

secondary colonoscopyprocedure

After the routine colonoscopy, a repeat colonoscopy of the sigmoid colon is performed

conventional colonoscopyprocedure

It starts from the rectum and progresses forward to the cecum, with observations made during withdrawal: from the cecum, ascending colon, transverse colon, descending colon, and sigmoid colon to the rectum.