Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy
Starting soon · Not applicable
Conditions studied: Colonoscopy Pain
In brief
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.
Key facts
- Study ID
- NCT07713953
- Run by
- Ningbo No. 1 Hospital
- People needed
- 106
- Starts
- 2026-07-20
- Expected to finish
- 2027-08-21
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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]).
You may not qualify if…
- 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.
Where it is running
- the First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.