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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07713953
- Acronym / sponsor ID
- 2026-R075-02
- Conditions
- Colonoscopy Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- 21 Aug 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Score-based Endoscopist Assignment | Experimental | Other: Risk Score-Based Endoscopist AssignmentHigh-risk patients (pre-procedural risk score >5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed ≥5,000 colonoscopy procedures. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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]).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Score-Based Endoscopist AssignmentHigh-risk patients (pre-procedural risk score >5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed at least 5,000 colonoscopy procedures. | Other | Risk Score-based Endoscopist Assignment |
Primary outcome
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.
7 secondary outcomes
Adenoma Detection Rate (ADR)
Time frame: At the time of colonoscopy (pathology results available within 1 week after procedure)
Willingness to Undergo Repeat Unsedated Colonoscopy
Time frame: Immediately after the colonoscopy procedure
Patient Satisfaction
Time frame: Immediately after the colonoscopy procedure
Cecal Intubation Time
Time frame: During the colonoscopy procedure
Withdrawal Time
Time frame: During the colonoscopy procedure
Abdominal Compression Use Rate
Time frame: During the colonoscopy procedure
Position Change Use Rate
Time frame: During the colonoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Score-Based Endoscopist Assignment in people with Colonoscopy Pain, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Xu (+86 13486659126, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy (time frame: Immediately after the colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.