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Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates

Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates:A Single-center, Randomized Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261319
Enrollment
614
Registered
2025-12-03
Start date
2025-12-15
Completion date
2027-12-15
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma

Keywords

transparent cap, adenoma detection rate, second examination, sigmoid colon

Brief summary

A prospective, single-center, single-blind, randomized controlled study to evaluate the clinical value of transparent cap-assisted second examination of the sigmoid colon for improving colorectal adenoma detection rates

Detailed description

Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with the increasing Westernization of diet and lifestyle, the incidence and prevalence of CRC in China have risen rapidly, making CRC one of the most common gastrointestinal malignancies in the country. Its incidence and mortality now rank second and fifth, respectively, among all cancers. The disease burden of CRC in China has become substantial, and reducing its incidence and mortality is an urgent public health priority. Colonoscopy is the gold standard for CRC screening, and timely endoscopic management of precancerous lesions plays a critical role in reducing both CRC incidence and mortality. Interval CRC refers to cancers diagnosed before the next recommended examination after a negative screening or surveillance colonoscopy. Adenoma detection rate (ADR) is an independent predictor of interval CRC risk; long-term follow-up data suggest that every 1% increase in ADR corresponds to a 5% reduction in the risk of interval CRC and a 3% reduction in mortality. However, emerging evidence indicates that interval CRC can still occur even among endoscopists with high ADRs, suggesting that some precancerous lesions may still be missed. The main contributors to missed colorectal adenomas include: (1) operator-related factors such as fatigue, reduced attention, or limited lesion recognition; (2) image-related factors such as low-resolution visualization; and (3) inadequate mucosal exposure due to residual folds. In recent years, several studies have explored the use of repeat intubation to reduce missed adenomas. Multiple randomized controlled trials (RCTs) and systematic reviews have shown that a second examination can increase ADR, but most studies have focused on the right colon and often relied on chromoendoscopy or other image-enhancement modalities to improve lesion visibility. Evidence regarding second intubation specifically for the sigmoid colon remains limited, and even fewer studies have evaluated interventions based on transparent cap-assisted colonoscopy. Given that the sigmoid colon is a common site for missed polyps and adenomas, optimizing visualization in this segment may have a significant impact on overall ADR and CRC prevention. In summary, there is still a lack of clinical evidence on whether transparent cap-assisted second intubation of the sigmoid colon can improve colorectal adenoma detection. A randomized controlled trial in the Chinese population is therefore needed to clarify its clinical value, with the potential to increase lesion detection and improve the overall quality of colonoscopy.

Interventions

DEVICEstandard second examination of the sigmoid colon

standard second examination of the sigmoid colon

DEVICEtransparent cap-assisted second examination of the sigmoid colon

transparent cap-assisted second examination of the sigmoid colon

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* aged 45-75 years

Exclusion criteria

* Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps * Patients with highly suspected or pathologically confirmed colorectal cancer * Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination) * Pregnant or breastfeeding women * Patients with gastrointestinal obstruction * Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome * Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders * Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days * Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum * A Boston Bowel Preparation Scale (BBPS) score \< 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing) * Use of non-guideline-recommended bowel preparation agents * Patients undergoing emergency colonoscopy * Inadequate withdrawal time (defined as a withdrawal time \<6 minutes during the first examination or \<2 minutes during the second examination)

Design outcomes

Primary

MeasureTime frame
Adenoma detection rate in the rectum and sigmoid colon2 weeks after the procedure

Secondary

MeasureTime frameDescription
Adenoma miss rate in the rectum and sigmoid colon2 weeks after the procedure
Per-colonoscopy adenoma miss rate in the rectum and sigmoid colon2 weeks after the procedure
Sessile serrated lesion detection rate in rectum and sigmoid colon2 weeks after the procedure
Advanced adenoma detection rate in rectum and sigmoid colon2 weeks after the procedure
Polyp detection rate in rectum and sigmoid colon2 weeks after the procedure
Increased adenoma detection rate in the rectum and sigmoid colon achieved by second examination2 weeks after the procedure
Advanced adenoma detection rate2 weeks after the procedure
Polyp detection rate2 weeks after the procedure
Perforation rateimmediately after the procedure
Clinically Significant Immediate Post-polypectomy Bleeding(CSIPB)rateimmediately after the procedureCSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis
Clinically Significant Delayed Post-polypectomy Bleeding(CSDPB)rate2 weeks after the procedureCSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
Sessile serrated lesion detection rate2 weeks after the procedure

Countries

China

Contacts

Primary ContactDanian Ji, M.D.
arctg4@163.com+86-18019094606
Backup ContactZhiyu Dong, M.D.
18817870866@163.com+86-18817870866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026