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

NCT06186778 | Completed

• 1 other identifier: 2023-KY-1332-002
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colorectal polyps; colonoscopy; repeat colonoscopy; detection rate; sigmoid colon

Outcome Measures

Primary Outcomes (1)

• Detection rate of sigmoid colon adenoma

  Number of patients with adenomas detected in the sigmoid colon in each group/number of patients examined in each group

  3 months

Secondary Outcomes (1)

• Detection rate of sigmoid colon polyps

  3 months

Study Arms (2)

conventional colonoscopy group

ACTIVE COMPARATOR

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.

Procedure: conventional colonoscopy

secondary colonoscopy group

EXPERIMENTAL

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

Procedure: secondary colonoscopy

Interventions

secondary colonoscopy PROCEDURE

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

secondary colonoscopy group

conventional colonoscopy PROCEDURE

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.

conventional colonoscopy group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent painless colonoscopy at the Gastrointestinal Endoscopy Center of the First Affiliated Hospital of Zhengzhou University and signed the informed consent for the clinical trial;
• Aged at age 45 and above with BMI \>24.

You may not qualify if:

• Patients with contraindications to colonoscopy: patients with acute diverticulitis, patients with known or suspected perforation, patients with severe cardiovascular and cerebrovascular lesions, patients with severe hepatic or renal insufficiency, patients with abdominal aneurysm of large arteries, patients with active hemorrhagic descending colonic lesions, patients with acute radiological colorectal inflammation, patients with advanced carcinomas with pelvic metastases or obvious ascites, patients with severe and extensive intestinal adhesions after abdominal or pelvic surgery;
• Patients with inflammatory bowel disease, colorectal cancer, familial adenomatous polyposis, Peutz-Jeghers syndrome, abdominal wall hernia, patients with a history of colorectal surgery;
• Patients with incomplete colonoscopy, i.e., those in whom the endoscopist has failed to successfully cannulate the cecum due to technical difficulties;
• Patients with poor bowel preparation, i.e., patients with a total score of \<6 or any bowel segment of \<2 on the Boston Bowel Preparedness Scale score for poor bowel preparation).

Sponsors & Collaborators

• Jianning Yao: lead

Study Sites (1)

Colonoscopy

Zhengzhou, Henan, 450000, China

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 29, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CN (1)