Global Evaluation of Cholecystectomy Knowledge and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is the compliance to pre-, intra-, and post-operative audit standards
研究概览
简要总结
Cholecystectomy, that is removing the gallbladder, is amongst the most common surgeries performed worldwide. There are mainly three approaches to performing it which are open, laparoscopic, and robotic. Laparoscopic cholecystectomy is currently the preferred for non-cancerous gallbladder disease namely gallstone disease. Since it is amongst the most common procedures, a lot of emphasis is placed on safety and quality assessment. Safe cholecystectomy is defined as which is safe for both the patient and the operating surgeon. Patient safety includes no injury to the adjoining structures around the gallbladder such as the bile duct and blood vessels.
There is a worldwide lack of evidence regarding the definitions of safety of this surgery. The present study that is Global Evaluation of Cholecystectomy Knowledge, and Outcomes (GECKO) intends to assess these worldwide differences and help to arrive at a common decision. All data on the quality of cholecystectomies will be noted. Patients undergoing open, laparoscopic, and robotic cholecystectomies in routine and emergency settings will be included. Global variation in adhering to the with pre-, intra-, and post-operative standards for cholecystectomy will be assessed along with the assessment of the provision of a safe cholecystectomy. Thus, by undertaking this study we will be assessing whether surgeons all over the world are able to adhere to the quality and safety standards of cholecystectomy.
Patients who give consent to enroll in this study will be receiving the same treatment as those who don’t enroll. There will be no change in treatment or surgical protocol. Only information related to their demographic details, postoperative period in the hospital, and one-year follow-up will be collected. It is important to understand that clinical care will remain the same irrespective of their enrolment in the study and participating patients will not undergo any extra investigations or procedures. Patients can withdraw their participation at any time they want without giving justification also. There will be no benefits, or compensation provided to participants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age All adult patients (greater than or including 18 years of age).
- •Procedure: Primary cholecystectomy, where this is the main procedure planned.
- •Approach: Open, laparoscopic (standard and single-port), and robotic.
- •Gasless laparoscopic and robotic approaches are inluded.
- •Laparoscopic and robot converted cases are also eligible.
- •Urgency: Elective, delayed and emergency procedures.
排除标准
- •Procedure: Patients having a cholecystectomy as a part of another surgical procedure; for example, Whipple’s procedure, bariatric, anti-reflux, or transplant operations, should be excluded.
- •Indication: Patients with Mirizzi syndrome should be excluded.
- •Return to theatre: Each patient should only be entered into the study once.
- •Any patient returning to theatre and requiring a cholecystectomy for whatever indication, should not be included.
- •Known gallbladder malignancy: when the diagnosis of gallbladder cancer is established pre- operatively, the patient should be excluded.
- •However, if gallbladder cancer is found unexpectedly during or after cholecystectomy (i.e. on histology), the patient should be included.
结局指标
主要结局
The primary endpoint of this study is the compliance to pre-, intra-, and post-operative audit standards
时间窗: 36 months
次要结局
- -Rates of achieving a critical view of safety.
研究者
Mahesh goel
Tata Memorial Hospital