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Recruiting NCT07541924

The Impact of Image-Assisted Colonoscope on Patient Experience, Physician Workload, and Examination Quality

No phase Interventional Colorectal Cancer Screening Colonic Polyps/Colonoscopy/Colorectal Neoplasms Difficult Colonoscopy Colonoscopy-Related Discomfort

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: CT-Based Image-Assisted Colonoscope Insertion.
Who it may be relevant to
Registry conditions: Colorectal Cancer Screening, Colonic Polyps/Colonoscopy/Colorectal Neoplasms, Difficult Colonoscopy, Colonoscopy-Related Discomfort. Basic parameters: 18 years — 80 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 →

Overview

Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. These features prolong insertion time, increase patient discomfort, and elevate physician workload. Evidence suggests that prior CT imaging can provide objective and individualized information on colonic anatomy-such as redundancy, angulation, and tortuosity-potentially predicting procedural difficulty. However, existing studies are mainly retrospective or descriptive, lacking prospective randomized evidence on clinical utility. This single-blind, randomized controlled trial evaluates whether image-assisted colonoscope insertion, based on pre-existing abdominal/pelvic CT scans, can improve cecal intubation time, enhance patient experience, reduce operator workload, and improve overall examination quality compared with standard colonoscopy.

Detailed description

Colonoscopy performance varies widely among patients, with anatomical factors being major contributors to insertion difficulty. Prior CT colonography studies demonstrate high interindividual variability in colon length, flexures, and tortuosity, and up to 73% of patients experience looping during colonoscopy. Fluoroscopy-guided maneuvers have been shown to resolve looping in \>95% of cases, highlighting the potential value of anatomical prediction.

This study investigates the feasibility and effectiveness of using information extracted from a patient's previous abdominal/pelvic CT scan (≤5 years) to guide insertion strategy during colonoscopy. Image-assisted guidance may help endoscopists anticipate looping patterns, identify redundant segments, and plan insertion maneuvers more effectively.

A total of 140 participants will be randomized 1:1 into an image-assisted group or standard group. The primary endpoint is cecal intubation time. Secondary endpoints include patient-reported pain (VAS), willingness for future colonoscopy, operator workload (NASA-TLX), looping events, total procedure time, and polyp detection rate. Consistency between CT-based predictions and actual procedural findings will also be assessed.

This trial will provide foundational evidence for individualized, anatomy-informed colonoscopy strategies and support future large-scale studies or AI-assisted implementation.

Interventions

  • Other CT-Based Image-Assisted Colonoscope Insertion
    This intervention uses pre-existing abdominal or pelvic CT imaging (within 5 years, without major abdominal surgery) to assess individual colonic morphology prior to colonoscopy. Key CT-derived features include colonic redundancy, looping patterns, fixation points, and segmental angulation. Based on these findings, the endoscopist receives a structured, standardized briefing before colonoscope insertion, including predicted difficult segments and recommended insertion strategies. No additional i

Primary outcome measures

  • Cecal Incubation Time (minutes) [Time frame: Periprocedural (during colonoscopy procedure)]
Secondary outcome measures (5)
  • Pain Score (VAS 0-10) [Time frame: Immediately after colonoscopy (periprocedural)]
  • Physician Workload [Time frame: Immediately after colonoscopy]
  • Willingness for Future Colonoscopy (5-point Likert scale) [Time frame: Immediately after colonoscopy]
  • Polyp Detection Rate (PDR) (%) [Time frame: During colonoscopy procedure]
  • Number of Looping Attempts [Time frame: During colonoscopy procedure]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years, or expected natural survival >3 years
  • Undergoing colonoscopy at Peking Union Medical College Hospital
  • Presence of an abdominal/pelvic CT scan performed within ≤5 years and no - - - major abdominal surgery afterward
  • Patient or legal guardian able to understand the study and provide written consent

Exclusion criteria

  • No available CT or CT quality insufficient for anatomical evaluation
  • Prior colonic surgery affecting anatomy (e.g., right hemicolectomy, transverse colectomy)
  • Severe cardiopulmonary dysfunction or coagulopathy
  • Pregnancy
  • Refusal to participate or inability to complete questionnaires
  • Patient or guardian unable to understand study requirements

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07541924 · P20251209-1001 · 2024YFA0918504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗