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

NCT06186778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

  • Colorectal Polyp

Interventions

PROCEDURE

secondary colonoscopy

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

PROCEDURE

conventional colonoscopy

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.

Sponsors & Collaborators

  • Jianning Yao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-04-30
Completion
2024-05-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186778 on ClinicalTrials.gov