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

NCT07541924 | Recruiting DMC

• 2 other identifiers: P20251209-10012024YFA0918504
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Screening; Colonic Polyps/Colonoscopy/Colorectal Neoplasms; Difficult Colonoscopy; Colonoscopy-Related Discomfort

Keywords

Colonoscopy; Cecal Intubation Time; Looping; Image-Assisted Colonoscopy; Personalized Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cecal Incubation Time (minutes)

  Time from scope insertion to visualization of the cecum

  Periprocedural (during colonoscopy procedure)

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Agreement Between CT-Based Prediction and Procedural Findings

  During colonoscopy procedure

Study Arms (2)

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.

Other: CT-Based Image-Assisted Colonoscope Insertion

Standard Colonoscopy

NO INTERVENTION

Participants undergo colonoscopy per routine clinical practice without CT-based anticipatory guidance.

Interventions

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.

Image-Assisted Colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DONG WU: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kun He, MD

CONTACT

15901623698; hk6290418@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: April 21, 2026
• Study Start: December 9, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)