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NCT Number: NCT07713953

Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy

This multicenter randomized controlled trial evaluates whether a pre-procedural risk score-based endoscopist assignment strategy reduces intraprocedural pain in high-risk patients undergoing unsedated colonoscopy. High-risk patients (risk score >5) are randomized 1:1 to either the intervention group (examination performed by expert endoscopists with ≥5,000 colonoscopy experiences) or the control group (examination performed by endoscopists assigned per routine hospital scheduling). The primary outcome is the proportion of patients reporting moderate-to-severe pain during colonoscopy, assessed by a blinded research assistant using a 4-point VRS. A total of 106 high-risk patients will be enrolled from two centers in China.

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Key information

Conditions

Colonoscopy Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-75 years.
  • Outpatient or inpatient undergoing colonoscopy for medical screening, polyp surveillance, or polypectomy.
  • Pre-procedural risk score >5 (based on the following scoring system: BMI <19 [5 points], female sex [1 point], history of abdominal or pelvic surgery [2 points], constipation [3 points]).

Exclusion criteria

  • Patients who have received sedation or analgesia prior to colonoscopy.
  • Patients unwilling to cooperate or unable to provide informed consent.
  • Incomplete intestinal obstruction.
  • Inflammatory bowel disease, multiple polyposis syndromes, or severe chronic cardiac or pulmonary disease.
  • Patients receiving anticoagulant therapy.

Treatment and study plan

Risk Score-Based Endoscopist Assignment

Other

High-risk patients (pre-procedural risk score >5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed at least 5,000 colonoscopy procedures.

Primary outcomes

  1. Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy

    Time frame: Immediately after the colonoscopy procedure

    Pain intensity is assessed using a VRS-4 ( none, mild, moderate, severe) immediately after the colonoscopy by a research assistant who is blinded to group allocation. Moderate or severe pain is defined as the primary outcome event.

Secondary outcomes

  1. Adenoma Detection Rate (ADR)

    Time frame: At the time of colonoscopy (pathology results available within 1 week after procedure)

    Proportion of participants with at least one histologically confirmed adenoma detected during colonoscopy. All resected polyps are sent for pathological examination.

  2. Willingness to Undergo Repeat Unsedated Colonoscopy

    Time frame: Immediately after the colonoscopy procedure

    Proportion of participants who respond "yes" when asked whether they would be willing to undergo a repeat unsedated colonoscopy in the future.

  3. Patient Satisfaction

    Time frame: Immediately after the colonoscopy procedure

    Patient satisfaction is assessed by a research assistant using a standardized questionnaire, graded as satisfied, fair, or dissatisfied.

  4. Cecal Intubation Time

    Time frame: During the colonoscopy procedure

    Time from endoscope insertion to successful cecal intubation, measured in minutes.

  5. Withdrawal Time

    Time frame: During the colonoscopy procedure

    Time taken for endoscope withdrawal from the cecum to the rectum, measured in minutes.

  6. Abdominal Compression Use Rate

    Time frame: During the colonoscopy procedure

    Proportion of participants requiring abdominal compression during the colonoscopy procedure.

  7. Position Change Use Rate

    Time frame: During the colonoscopy procedure

    Proportion of participants requiring position change during the colonoscopy procedure.

Study contacts

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

Lei Xu

CONTACT

[email protected]

+86 13486659126

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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