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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Cecal Incubation Time (minutes) [Срок оценки: Periprocedural (during colonoscopy procedure)]

Вторичные конечные точки (5)

• Pain Score (VAS 0-10) [Срок оценки: Immediately after colonoscopy (periprocedural)]
• Physician Workload [Срок оценки: Immediately after colonoscopy]
• Willingness for Future Colonoscopy (5-point Likert scale) [Срок оценки: Immediately after colonoscopy]
• Polyp Detection Rate (PDR) (%) [Срок оценки: During colonoscopy procedure]
• Number of Looping Attempts [Срок оценки: During colonoscopy procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07541924 · P20251209-1001 · 2024YFA0918504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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