Colonoscopy Pain
Conditions
Brief 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. 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.
Interventions
OTHERRisk Score-Based Endoscopist Assignment
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.
Sponsors
Ningbo No. 1 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (ADR) | 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. |
| Willingness to Undergo Repeat Unsedated Colonoscopy | 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. |
| Patient Satisfaction | Immediately after the colonoscopy procedure | Patient satisfaction is assessed by a research assistant using a standardized questionnaire, graded as satisfied, fair, or dissatisfied. |
| Cecal Intubation Time | During the colonoscopy procedure | Time from endoscope insertion to successful cecal intubation, measured in minutes. |
| Withdrawal Time | During the colonoscopy procedure | Time taken for endoscope withdrawal from the cecum to the rectum, measured in minutes. |
| Abdominal Compression Use Rate | During the colonoscopy procedure | Proportion of participants requiring abdominal compression during the colonoscopy procedure. |
| Position Change Use Rate | During the colonoscopy procedure | Proportion of participants requiring position change during the colonoscopy procedure. |
Countries
China
Contacts
CONTACTLei Xu
Outcome results
None listed