Difficulty in Laparoscopic Cholecystectomy Score Can Determine the Operative Challenge.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC)
研究概览
简要总结
Laparoscopic cholecystectomy is the gold standard treatment method in symptomatic gallstone disease. However, complications that develop due to being a technical procedure tend to be more complex and more morbid-estimating how difficult the surgery will be before the operation will enable us to be more prepared both in terms of patient counseling and surgical team selection. Such a prediction will minimize the risk of complications and morbidity.
In our study, investigators used the scoring system "How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system?" which was published in "The American Journal of Surgery" in November 2016. Investigators wanted to evaluate prospectively adequate "Laparoscopic Cholecystectomy Difficulty Score," which was developed retrospectively, in determining the surgical difficulty preoperatively.
详细描述
ETHICAL BOARD APPROVAL
Konya Chamber of Commerce Education and Health Foundation was found ethically appropriate for the study according to the decision of Karatay University Ethical Board Presidency dated 18.06.2019 and numbered 2019/0051.
FEATURES OF THE STUDY AND SELECTION OF PATIENTS
Patients who were to be operated due to symptomatic cholelithiasis between 01.03.2020 and 31.07.2020 at the Health Sciences University (SBU) Konya Training and Research Hospital (KEAH) were included in the study. The study was done prospectively.
Laparoscopic Cholecystectomy Difficulty Score (DSLC) developed in the reference study will be used. The sex of the patients and whether they had an attack of cholecystitis will be recorded. Neutrophil count, fibrinogen, and ALP levels will be recorded from preoperatively routine blood tests. DSLC score will be calculated before the patient goes into surgery. How successful the scoring system is in determining the difficulty of the operation in the postoperative period will be analyzed statistically.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be operated for biliary colic, chronic cholecystitis or symptomatic cholelithiasis,
- •Patients who have been treated with antibiotics before with the diagnosis of cholecystitis and have been planned for elective cholecystectomy,
- •Patients diagnosed with acute cholecystitis according to Tokyo criteria and cholecystectomy planned due to acute cholecystitis
排除标准
- •Patients under the age of 18,
- •Patients over 100 years old,
- •Patients diagnosed with choledocholithiasis with magnetic resonance cholangiopancreatography (MRCP),
- •Patients with cholangitis
- •Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP),
- •Patients who have undergone biliary system intervention before,
- •Patients scheduled for operation open cholecystectomy
结局指标
主要结局
Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC)
时间窗: The period of the study is between 1 March 2020 and 15 August 2020.
Laparoscopic cholecystectomy scores of patients included in the study will be recorded. The relationship between the scoring system and the fact that the cases are easy or difficult will be analyzed statistically, in which predictive values determine the difficulty of the operation. The study will be terminated with the completion of the analysis.
次要结局
未报告次要终点
研究者
Erguvan Nalıncıoğlu
principal investigator
Konya Meram State Hospital