Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 346
- 试验地点
- 2
- 主要终点
- Mean Cecal Intubation Time
研究概览
简要总结
Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
- •Participants with ASA I-III (American Society of Anesthesiologists Class III)
排除标准
- •Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia
结局指标
主要结局
Mean Cecal Intubation Time
时间窗: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes
Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum
次要结局
- Number of Participants Who Completed the Procedure(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes)
- Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes)
- Number of Participants Who Required Ancillary Maneuvers(During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes)
- Length of Cecal Intubation(From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes)
- Patient Pain and Comfort Level at Discharge(At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes)
- Number of Participants According to Colonoscopy Findings(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes)
研究者
Beslen Goksoy
Principal Investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital