Colonoscopy PainNCT07713953
Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy
A study testing Risk Score-Based Endoscopist Assignment in people with Colonoscopy Pain, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Pain
- What is being tested?
- Risk Score-Based Endoscopist Assignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 21 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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]).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Lei Xu, MD, +86-13486659126, xulei22@163.com
About this study
Official title: Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial
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.
- Conditions
- Colonoscopy Pain
- Being tested
- Risk Score-Based Endoscopist Assignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Score-Based Endoscopist AssignmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Risk Score-based Endoscopist Assignment | Experimental | High-risk patients (pre-procedural risk score >5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed ≥5,000 colonoscopy procedures. Receives: Other: Risk Score-Based Endoscopist Assignment |
| Routine Hospital Scheduling Assignment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the colonoscopy procedure
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Immediately after the colonoscopy procedure
Cecal Intubation Time
Time from endoscope insertion to successful cecal intubation, measured in minutes.
Measured: During the colonoscopy procedure
Withdrawal Time
Time taken for endoscope withdrawal from the cecum to the rectum, measured in minutes.
Measured: During the colonoscopy procedure
Abdominal Compression Use Rate
Proportion of participants requiring abdominal compression during the colonoscopy procedure.
Measured: During the colonoscopy procedure
Position Change Use Rate
Proportion of participants requiring position change during the colonoscopy procedure.
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion21 Jul 2027 (estimated)
- Study completion21 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713953
- Sponsor's protocol ID
- 2026-R075-02
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No