An interventional study of Risk Score-Based Endoscopist Assignment in Colonoscopy Pain, sponsored by Ningbo No. 1 Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Supportive care
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 106 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-risk patients (pre-procedural risk score \>5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed ≥5,000 colonoscopy procedures.
Other: Risk Score-Based Endoscopist Assignment
High-risk patients (pre-procedural risk score \>5) undergoing unsedated colonoscopy are assigned to endoscopists according to routine hospital scheduling, which may include both expert and non-expert endoscopists.
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.
Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy
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.
Time frame: Immediately after the colonoscopy procedure
Adenoma Detection Rate (ADR)
Proportion of participants with at least one histologically confirmed adenoma detected during colonoscopy. All resected polyps are sent for pathological examination.
Time frame: At the time of colonoscopy (pathology results available within 1 week after procedure)
Willingness to Undergo Repeat Unsedated Colonoscopy
Proportion of participants who respond "yes" when asked whether they would be willing to undergo a repeat unsedated colonoscopy in the future.
Time frame: Immediately after the colonoscopy procedure
Patient Satisfaction
Patient satisfaction is assessed by a research assistant using a standardized questionnaire, graded as satisfied, fair, or dissatisfied.
Time frame: Immediately after the colonoscopy procedure
Cecal Intubation Time
Time from endoscope insertion to successful cecal intubation, measured in minutes.
Time frame: During the colonoscopy procedure
Withdrawal Time
Time taken for endoscope withdrawal from the cecum to the rectum, measured in minutes.
Time frame: During the colonoscopy procedure
Abdominal Compression Use Rate
Proportion of participants requiring abdominal compression during the colonoscopy procedure.
Time frame: During the colonoscopy procedure
Position Change Use Rate
Proportion of participants requiring position change during the colonoscopy procedure.
Time frame: During the colonoscopy procedure
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ningbo No. 1 Hospital