Safety of Laparoscopic ChOlecystectomy Performed by Trainee Surgeons With Different CHolangiographic Techniques
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Time to obtain the CVS during laparoscopic cholecystectomy
研究概览
简要总结
Laparoscopic cholecystectomy (LC) gained popularity among general surgeons in 1990s and rapidly become one of the most commonly performed procedures in digestive surgery, with more than one million cholecystectomies being performed in the United States per year. LC remains also one of the most commonly performed procedure by general surgeons during the training period. Even if previous report LC cases performed by surgical trainees (ST) are not associated with higher operative morbidity, the length of operative time is significantly increased when compared with that of LC cases performed by attending surgeons, due, most of all, to difficulties in identifying the anatomical structure, and this sometimes leads to an attending surgeon taking away the case from the trainee. Furthermore, despite the fact that LC has proven to be a safe procedure, the rate of common bile duct (BDI) injury still remains unacceptably high even in the hands of minimally invasive trained surgeons ranging from 0.2 to 1.5% in individual reports, much higher than initial reports, associated with significant morbidity and mortality, lower quality of life and increased costs, related to additional health care measures, loss of work days, and insurance claims. The aim of this study is to address which of the techniques now available could be addressed as the best option in a training setting to enhance the learning curve, to ideally build a safe cholecystectomy training program and virtually eliminate the risk of BDI due to anatomic misinterpretation during the training period.
详细描述
Study design The study will be a multicentre prospective observational study. Members of the Italian Society of Endoscopic Surgery [SICE] will be invited to participate. All participating centers will be required to register the study according to local regulations. Evidence of successful registration should be sent to your national network committee prior to beginning of data collection.
Rationale for Study Design Since to date there is no consensus on which is the best technique to correctly identify the anatomy of the Calot's triangle during LC performed by ST, this trial would aim to propose a standard technique to be used in this peculiar setting.
Potential Benefit for Patients In teaching hospitals and, more generally in a training setting, overcoming the problem of providing high surgical quality while educating ST can be challenging. This may change in the future if residents are able to better identify the anatomy with Intra-operative fluorescent cholangiography (IOIFC), shortening the learning curve and improving the safety profile of LC, that, in a clinical point of view, would translate into a shorter operative times and reduction of the potential risk of BDI.
Patient Risk There are no additional risks on the participation of this study as no additional procedures are being performed to clinical guidance. In accordance with standard care, patients shall receive written information regarding the index procedure.
Evaluated parameters i) Age ii) Sex iii) ASA scores iv) Preoperative work up v) Type of procedure (CVS-WL, NIFC, IOC) vi) Operative parameters (operative time, intraoperative complications) vii) BDI (according to the ATOM classification) viii) How the BDI was diagnosed intraoperatively ix) Duration of cholangiography x) Time needed to obtain a CVS xi) Post-operative outcomes (post-operative complications, late complications, need of readmission, length of hospital stay) xii) Surgeons' ease at performing the procedure (questionnaire on identification of anatomical structures, NASA task load test) xiii) Surgeons' satisfaction (visual analog scale)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for elective laparoscopic cholecystectomy
- •Patient age ≥ 18 years
- •Patient able to give consent to the procedure
排除标准
- •Open cholecystectomy
- •Emergency laparoscopic cholecystectomy
- •Allergy towards iodine or indocyanine green
- •Liver or renal insufficiency
- •Thyrotoxicosis
- •Pregnancy or lactation
- •Legally incompetent for any reason
- •Withdrawal of inclusion consent at any time
- •Age outside inclusion range
结局指标
主要结局
Time to obtain the CVS during laparoscopic cholecystectomy
时间窗: operative period
The primary objective is to compare NIFC, IOC and CVS-WL for identification of the junction between the cystic duct, the common hepatic duct and the CBD during LC performed by general surgery trainee always supported by an expert surgeon. The technique will be considered successful when the CVS will be achieved. The time to achieve the CVS will be recorded by an independent surgeon who will be present in the operative room during the procedure
次要结局
- Type of BDI(operative period)
- short term complications (reported with a descriptive name of scale and entered in an excel sheet)(up to 30 days from operation)
- Operative time(operative period)
- Intraoperative complications will be recorded namely as a descriptive variable and at the end of the study the frequency of each complication will be reported(operative period)
- Causes for conversion will be reported as a descriptive variable and at the end of the study frequencies will be reported(operative period)
- Need for conversion will be reported as a binomial variable and participants will be asked to feel the appropriate spaces with a 1 for yes and 0 for no, at the end the frequency of conversion occurrence will be provided(operative period)
- Intensive care unit stay(up to 24 weeks)
- length of hospital stay(through study completion, an average of 1 year)
- Type of post-operative admission(immediate post-operative period)
- rate of BDI(operative period)
研究者
Monica Ortenzi
principal investigator
Università Politecnica delle Marche