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Not yet recruiting NCT07097350

Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas

No phase Interventional Colorectal Adenoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: computer-aided detection alone, transparent cap-assisted colonoscopy combined with computer-aided detection.
Who it may be relevant to
Registry conditions: Colorectal Adenoma. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study on the Effect of Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas

Overview

A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate

Detailed description

1. Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University. 2. Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection. 3. Collecting variables which consist of primary and secodary outcomes.

Interventions

  • Device computer-aided detection alone
    colonoscopy with computer-aided detection
  • Device transparent cap-assisted colonoscopy combined with computer-aided detection
    transparent cap-assisted colonoscopy combined with computer-aided detection

Primary outcome measures

  • adenoma detection rate [Time frame: 2 weeks after the procedure]
Secondary outcome measures (6)
  • sessile serrated lesion detection rate [Time frame: 2 weeks after the procedure]
  • advanced adenoma detection rate [Time frame: 2 weeks after the procedure]
  • polyp detection rate [Time frame: 2 weeks after the procedure]
  • Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate [Time frame: immediately after the procedure]
  • Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate [Time frame: 2 weeks after the procedure]
  • perforation rate [Time frame: immediately after the procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huadong hospital, Fudan university — Shanghai

Identifiers

NCT: NCT07097350 · 2025K239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗