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NCT Number: NCT07541924

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

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.

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Key information

Conditions

Colorectal Cancer Screening Colonic Polyps Colonic Polyps/Colonoscopy/Colorectal Neoplasms Colonoscopy-Related Discomfort Difficult Colonoscopy Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Dong Wu, M.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cecal Incubation Time (minutes)

    Time frame: Periprocedural (during colonoscopy procedure)

    Time from scope insertion to visualization of the cecum

Secondary outcomes

  1. Pain Score (VAS 0-10)

    Time frame: Immediately after colonoscopy (periprocedural)

    Patient-reported pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Physician Workload

    Time frame: Immediately after colonoscopy

    NASA-TLX Score (0-100)

  3. Willingness for Future Colonoscopy (5-point Likert scale)

    Time frame: Immediately after colonoscopy

    Patient willingness to undergo repeat colonoscopy assessed using a 5-point Likert scale.

  4. Polyp Detection Rate (PDR) (%)

    Time frame: During colonoscopy procedure

    Proportion of colonoscopies in which at least one polyp is detected.

  5. Number of Looping Attempts

    Time frame: During colonoscopy procedure

    Total number of looping events requiring corrective maneuvers during colonoscope insertion.

Other outcomes

  1. Agreement Between CT-Based Prediction and Procedural Findings

    Time frame: During colonoscopy procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun He, MD

CONTACT

[email protected]

15901623698

Sponsors and collaborators

Lead sponsor

DONG WU

Other

Registry information

Acronym: LOOP-p1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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