Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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]).
排除标准
- •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.
结局指标
主要结局
Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy
时间窗: 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.
次要结局
- Adenoma Detection Rate (ADR)(At the time of colonoscopy (pathology results available within 1 week after procedure))
- Willingness to Undergo Repeat Unsedated Colonoscopy(Immediately after the colonoscopy procedure)
- Patient Satisfaction(Immediately after the colonoscopy procedure)
- Cecal Intubation Time(During the colonoscopy procedure)
- Withdrawal Time(During the colonoscopy procedure)
- Abdominal Compression Use Rate(During the colonoscopy procedure)
- Position Change Use Rate(During the colonoscopy procedure)