NCT06186778

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

Completed NA Last updated 10 June 2024

What this trial tests

NA trial testing secondary colonoscopy in Colorectal Polyp in 650 participants. Completed in 29 May 2024.

Timeline

1 January 2024

Primary endpoint
30 April 2024

29 May 2024

Quick facts

Lead sponsor	Jianning Yao
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	650
Start date	1 January 2024
Primary completion	30 April 2024
Estimated completion	29 May 2024
Sites	1 location across China

Drugs / interventions tested

• secondary colonoscopy
• conventional colonoscopy

Conditions studied

• Colorectal Polyp — all drugs for Colorectal Polyp →

Sponsor

Jianning Yao

Who can join

45 and older, any sex, with Colorectal Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.