PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
研究概览
简要总结
Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.
详细描述
Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18-70)
- •Ulcerative Colitis history
- •Suffering from symptoms such as hematochezia, diarrhea or abdominal pain
排除标准
- •Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
- •Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
- •Patients with a history of Crohn's disease
- •Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.
结局指标
主要结局
Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)
次要结局
- the Mayo score of each case
- the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion)
- clinical data such as age, gender,chief complaint
- the quality of colonic preparation
研究者
Zhizheng Ge
Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine