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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDONG WU

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • CT-Based Image-Assisted Colonoscope Insertion

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Image-Assisted ColonoscopyExperimental treatment 1 intervention
Group B: Standard ColonoscopyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Cecal Incubation Time (minutes)

Time from scope insertion to visualization of the cecum

Time frame
Periprocedural (during colonoscopy procedure)

Secondary outcomes

1

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)
2

Physician Workload

NASA-TLX Score (0-100)

Time frame
Immediately after colonoscopy
3

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
4

Polyp Detection Rate (PDR) (%)

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

Time frame
During colonoscopy procedure

Other outcomes

1

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DONG WU

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution