An interventional study of CT-Based Image-Assisted Colonoscope Insertion in Colorectal Cancer Screening, Colonic Polyps/Colonoscopy/Colorectal Neoplasms and Difficult Colonoscopy, sponsored by DONG WU. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by DONG WU · Not applicable, Interventional, and Health services research
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.
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 200 is below the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →This is the only study on the registry with DONG WU as lead sponsor.
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Exclusion Criteria:
Participants undergo colonoscopy with pre-procedural review of their existing abdominal/pelvic CT scan (≤5 years). Endoscopists complete a standardized imaging assessment form including predicted redundancy, looping type, tortuosity, and segmental laxity. No additional imaging is performed.
Other: CT-Based Image-Assisted Colonoscope Insertion
Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance.
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.
Cecal Incubation Time (minutes)
Time from scope insertion to visualization of the cecum
Time frame: Periprocedural (during colonoscopy procedure)
Pain Score (VAS 0-10)
Patient-reported pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Immediately after colonoscopy (periprocedural)
Physician Workload
NASA-TLX Score (0-100)
Time frame: Immediately after colonoscopy
Willingness for Future Colonoscopy (5-point Likert scale)
Patient willingness to undergo repeat colonoscopy assessed using a 5-point Likert scale.
Time frame: Immediately after colonoscopy
Polyp Detection Rate (PDR) (%)
Proportion of colonoscopies in which at least one polyp is detected.
Time frame: During colonoscopy procedure
Number of Looping Attempts
Total number of looping events requiring corrective maneuvers during colonoscope insertion.
Time frame: During colonoscopy procedure
Agreement Between CT-Based Prediction and Procedural Findings
Agreement between pre-procedural CT-based anatomical predictions and actual procedural findings, including predicted looping type, colonic redundancy, and insertion difficulty grade, assessed using Cohen's kappa statistics.
Time frame: During colonoscopy procedure
Plan to share: No — The individual participant data (IPD) will not be shared. Only aggregated results will be published.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Jan 2026, 1 month.
Of 132 non-industry interventional studies with no phase under Colonic Polyps, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 1 month is below that.
Counting every sponsor, half of 149 studies reached it within 17 months; a quarter within 9 and three quarters within 35.
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