A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange During on Demand Sedation Colonoscopy in Diagnostic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 6
- 主要终点
- Maximum pain score recorded during colonoscopy.
研究概览
简要总结
Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.
详细描述
Introduction Water-aided methods for colonoscopy can be broadly subdivided into two major categories.
Water Immersion (WI) is characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy and Water Exchange (WE) is characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.
Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.
Method
Examinations will be allocated to Water Exchange, Water Immersion or Air Insufflation during the insertion phase of colonoscopy based on a computer generated random list. Procedures will be started by 6 board-certified endoscopists, three with experience in 8,000-10,000 and three with experience in 2,000-5,000 colonoscopies with AI, 285 with WI and 890 with WE overall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive 18 to 85 year-old first time diagnostic in-patients and outpatients agreeing to start procedure without premedication.
排除标准
- •patient unwillingness to start the procedure without sedation/analgesia
- •previous colorectal surgery
- •indication for a proctosigmoidoscopy or bidirectional endoscopy
- •patient refusal or inability to provide informed consent
- •inadequate bowel preparation (patients unable to swallow at least ¾ of cleansing preparation, or that did have late and insufficient evacuations, or that reported the presence of residual stools in the last evacuations).
结局指标
主要结局
Maximum pain score recorded during colonoscopy.
时间窗: 1 hour
Pain will be assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. The patient will be informed that the request for pain information is not to remind the patient that the examination should be uncomfortable, but to let the colonoscopist be alerted to the need to use maneuvers to minimize discomfort (e.g. loop reduction, removal of colonic content, abdominal compression and/or change in patient position). At regular intervals during colonoscopy (e.g. every 2-3 minutes) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.
次要结局
- Need for sedation/analgesia and its dosage.(1 hour)
- Total procedure time.(1 hour)
- Adenoma detection rate.(6 months)
- Adenoma resection rate.(6 months)
- Overall pain after the procedure.(1 hour.)
- Cecal intubation time.(1 hour)
- Cecal intubation rate.(1 hour)
- Advanced adenoma.(6 months)
研究者
Sergio Cadoni, M.D.
Responsabile Servizio Endoscopia Digestiva
Presidio Ospedaliero Santa Barbara