Clinical Audit of GI Endoscopic Complications in a Tertiary Care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42,471
- 试验地点
- 1
- 主要终点
- Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
研究概览
简要总结
Endoscopy of the upper gastrointestinal tract using fiberoptic endoscopes was introduced in the late 1950s and provided the first opportunity for direct visualization of the esophagus, stomach, and duodenum and colon in vivo. GI Endoscopy is usually considered a safe and effective procedure. However complications do exist and procedure related costs are significant. There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures.There is a lack of prospective studies on complications of diagnostic and therapeutic endoscopic procedures. Knowledge of potential endoscopic adverse events, their expected frequency, and the risk factors for their occurrence may help to minimize the incidence of adverse events. Review of adverse events as part of a continuing quality improvement process may serve to educate endoscopists, help to reduce the risk of future adverse events, and improve the overall quality of endoscopy.
详细描述
- STUDY OBJECTIVES
1a. Primary objective - Clinical audit of complications in gastrointestinal endoscopy unit from a tertiary care centre.
1b. Secondary objective - NA
-
STUDY POPULATION- Consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration and develops a complication.
-
DESIGN AND DURATION OF THE STUDY- It will be an observational prospective audit of all consecutive patients coming to the hospital for any gastrointestinal endoscopic procedure for 6 months duration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who undergo any diagnostic or therapeutic endoscopic procedure during the period and develop any complication including:
- •Diagnostic and therapeutic upper gastrointestinal endoscopy,
- •Diagnostic and therapeutic colonoscopy,
- •Endoscopic retrograde cholangiopancreatography (ERCP),
- •Endoscopic Ultrasound (EUS),
- •Peroral Endoscopic Myotomy (POEM),
- •Enteroscopy (Antegrade, Retrograde or spiral)
- •Endoscopic mucosal resection (EMR),
- •Endoscopic Submucosal Resection (ESD),
- •Submucosal Tunnel Endoscopic Resection (STER)
- •Anti- Reflex Mucosal Ablation (ARMA)
- •Anti- Reflex Mucosal Resection (ARMS)
- •Endoscopic Sleeve Gastrectomy (ESG)
- •Intra-gastric Balloon insertion
排除标准
- •Those who are not willing to give the consent.
结局指标
主要结局
Clinical audit of GI Endoscopic complications in a Tertiary Care Hospital
时间窗: 6 months
The study aims to do audit of all endoscopic procedures occurring over six months duration and record any complications occurring during that period. Information related to the complications will be recorded.
次要结局
- Risk factors for endoscopy complications(6 months)
- Morbidity associated with endoscopic complications(6 months)
