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

ConditionColorectal Adenoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorFudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 45-75 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • standard second examination of the sigmoid colon

    Device

    standard second examination of the sigmoid colon

  • transparent cap-assisted second examination of the sigmoid colon

    Device

    transparent cap-assisted second examination of the sigmoid colon

Treatment groups

614 Participants
are divided into 2 treatment groups
Group A: Standard second examination of the sigmoid colonActive comparator 1 intervention
Group B: transparent cap-assisted second examination of the sigmoid colonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adenoma detection rate in the rectum and sigmoid colon

Time frame
2 weeks after the procedure

Secondary outcomes

1

Increased adenoma detection rate in the rectum and sigmoid colon achieved by second examination

Time frame
2 weeks after the procedure
2

Adenoma miss rate in the rectum and sigmoid colon

Time frame
2 weeks after the procedure
3

Per-colonoscopy adenoma miss rate in the rectum and sigmoid colon

Time frame
2 weeks after the procedure
4

Sessile serrated lesion detection rate in rectum and sigmoid colon

Time frame
2 weeks after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: