Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- Mean colonoscopic insertion time
研究概览
简要总结
Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. 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
- Single (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults between the ages of 40 - 80
- •Undergoing a colonoscopy at any of the study locations for:
- •i. CRC screening (first colonoscopy or 10 year follow up of negative exam). ii. Surveillance (prior colonoscopy with polyps). iii. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.
- •Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
- •For the purposes of informed consent, participants must be able to understand and read English.
排除标准
- •Inability to provide informed consent
- •Active or suspected pregnancy
- •Patients referred due to incomplete colonoscopy or for removal of difficult polyps
- •History of problems with sedation or anesthesia -. Participants electing to be unsedated for colonoscopy
- •Patients undergoing multiple procedures (e.g. upper and lower endoscopy)
- •Previous colon resection surgery
- •Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •Patients with a history of colorectal cancer or other intra-abdominal malignancy.
- •Patients with open or recent wounds or skin rash on the anterior abdominal wall.
- •History of cirrhosis or ascites
- •Known ventral or umbilical hernia
- •Patients who are medically unstable(American Society of Anesthesiology Class III or above).
结局指标
主要结局
Mean colonoscopic insertion time
时间窗: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Colonoscopic insertion 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
- Frequency of prolonged, difficult cases(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum)
- Time to patient discharge(From time point in which scope is removed from patient's rectum following a colonoscopy until the time the patient is discharged from the facility)
- Operator perception of patient discomfort(During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified)
- Drug and Dosage Required to Complete Procedure(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum)
- Colonoscopy Completion Rate(During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum)
- Frequency of use of ancillary maneuvers(During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified)
- Patient Pain, Bloating, and Satisfaction at Discharge(At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility)
- Operator's Assessment of Procedural Difficultly(During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified)
- Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure(During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified)