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| ID | Type | Description | Link |
|---|---|---|---|
| 2024YFA0918504 | Other Identifier | National Key Research and Development Program of China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image-Assisted Colonoscopy | Experimental | 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. |
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| Standard Colonoscopy | No Intervention | Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-Based Image-Assisted Colonoscope Insertion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cecal Incubation Time (minutes) | Time from scope insertion to visualization of the cecum | Periprocedural (during colonoscopy procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately after colonoscopy (periprocedural) |
| Physician Workload |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During colonoscopy procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun He, MD | Contact | 15901623698 | hk6290418@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
The individual participant data (IPD) will not be shared. Only aggregated results will be published.
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|
NASA-TLX Score (0-100)
| Immediately after colonoscopy |
| Willingness for Future Colonoscopy (5-point Likert scale) | Patient willingness to undergo repeat colonoscopy assessed using a 5-point Likert scale. | Immediately after colonoscopy |
| Polyp Detection Rate (PDR) (%) | Proportion of colonoscopies in which at least one polyp is detected. | During colonoscopy procedure |
| Number of Looping Attempts | Total number of looping events requiring corrective maneuvers during colonoscope insertion. | During colonoscopy procedure |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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