The Impact of Image-Assisted Colonoscope on Patient Experience, Physician Workload, and Examination Quality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cecal Incubation Time (minutes)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Image-Assisted Colonoscopy
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.
干预措施: CT-Based Image-Assisted Colonoscope Insertion (Other)
Standard Colonoscopy
Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance.
结局指标
主要结局
Cecal Incubation Time (minutes)
时间窗: Periprocedural (during colonoscopy procedure)
Time from scope insertion to visualization of the cecum
次要结局
- Pain Score (VAS 0-10)(Immediately after colonoscopy (periprocedural))
- Physician Workload(Immediately after colonoscopy)
- Willingness for Future Colonoscopy (5-point Likert scale)(Immediately after colonoscopy)
- Polyp Detection Rate (PDR) (%)(During colonoscopy procedure)
- Number of Looping Attempts(During colonoscopy procedure)
研究者
DONG WU
Professor of Medicine
Peking Union Medical College Hospital