Colonic Polyps/Colonoscopy/Colorectal Neoplasms, Colonoscopy-Related Discomfort, Colorectal Cancer Screening, Difficult Colonoscopy
Conditions
Keywords
Colonoscopy, Cecal Intubation Time, Looping, Image-Assisted Colonoscopy, Personalized Colonoscopy
Brief summary
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
OTHERCT-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 imaging, radiation, or invasive procedures are used. The intervention aims to improve insertion efficiency, reduce patient discomfort, and lower operator workload compared with standard colonoscopy without image guidance.
Sponsors
DONG WU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cecal Incubation Time (minutes) | Periprocedural (during colonoscopy procedure) | Time from scope insertion to visualization of the cecum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (VAS 0-10) | Immediately after colonoscopy (periprocedural) | Patient-reported pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). |
| Physician Workload | Immediately after colonoscopy | NASA-TLX Score (0-100) |
| Willingness for Future Colonoscopy (5-point Likert scale) | Immediately after colonoscopy | Patient willingness to undergo repeat colonoscopy assessed using a 5-point Likert scale. |
| Polyp Detection Rate (PDR) (%) | During colonoscopy procedure | Proportion of colonoscopies in which at least one polyp is detected. |
| Number of Looping Attempts | During colonoscopy procedure | Total number of looping events requiring corrective maneuvers during colonoscope insertion. |
Countries
China
Contacts
CONTACTKun He, MD
Outcome results
None listed