CTRI/2026/04/107678尚未招募不适用
IMPACT CHOLE: Assessment of Morbidity and Burden of Illness through a Tracking Initiative in a Prospective, Observational Study of Cholecystitis
Intuitive Surgical India Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2026年5月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 试验地点
- 1
研究概览
简要总结
Cholecystectomy is one of the most commonly performed general surgical procedures. The purpose of this study is to evaluate the quality of life, pain and cost outcomes following laparoscopic cholecystectomy (LC) or robotic-assisted cholecystectomy (RAC). The goal of this real-world observational study is to generate essential data on quality of life and pain outcomes following LC or RAC.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18 years or more) undergoing cholecystectomy for cholecystitis/gallstone disease.
- •The subject is scheduled to undergo cholecystectomy for acute cholecystitis classified as grade I or II, as assessed by the physician in accordance with the Tokyo guidelines.
排除标准
- •The subject has a contraindication to general anesthesia or surgical procedures.
- •The subject has been taking daily pain medications for more than 6 weeks.
- •The subject is scheduled to undergo a concomitant procedure.
- •The subject has a known bleeding or coagulation disorder.
- •The subject is pregnant or suspected to be pregnant.
- •The subject has a psychological or psychiatric disorder, or a severe systemic illness that may hinder compliance with study requirements or the ability to provide informed consent.
- •The subject is currently enrolled in another interventional or investigational research study.
研究者
Dr Virinder Kumar Bansal
All India Institute of Medical Sciences
研究点 (1)
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