NCT01126281Unknown4 期
THE USE OF FLOSEAL GELATIN MATRIX FOR THE HAEMOSTASIS DURING LAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS; EFFICACY AND SAFETY EVALUATED IN A MULTICENTER, PROSPECTIVE, OPEN LABEL TRIAL WITH AN HISTORICAL CONTROL GROUP. (G.L.A. STUDY: GELATIN Matrix in Laparoscopic Cholecystectomy for Acute Cholecystitis)
University of Bologna2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
研究概览
简要总结
The aim of this study is to evaluate the effect and safety of Floseal in this preliminary prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute cholecystitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 - 65
- •Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of cholecystitis
- •Surgical indication for laparoscopic cholecystectomy
- •ASA class I-III
- •Informed consent
- •<72 hours from onset of symptoms
排除标准
- •Informed consent refusal
- •Choledocholithiasis
- •Pre surgical generalized peritonitis (clinical evaluation)
- •ASA class > III
- •Peripheral artery disease
- •Active or past history of malignant systemic disease
- •Pregnant or lactating females
- •Known allergy to components Floseal including bovine allergy (bovine gelatin)
- •Known drug or alcohol abuse
- •Patients with known diabetes, chronic renal disease and other metabolic diseases
- •Patients in chronic cortisone treatment more than 2 years before surgery
- •Patients on chronic use of platelet inhibitors such as Aspirin, Plavix, NSAID's etc.
结局指标
主要结局
to evaluate the percentage of patients with complete haemostasis 10 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.
时间窗: 10 minutes
次要结局
- • Percentage of patients with complete haemostasis evaluated at 2, 4 and 6 minutes after laparoscopic application of haemostatic agent (Floseal) to the gall bladder bed.(6 minutes)
- • Safety evaluated as number of patients with adverse events and serious adverse events until end of the study.(3 year)
- • Percentage of patients with conversion from laparoscopic procedure to open laparotomy (conversion rate).(3 year)
- • Percentage of patients developing post operative bleeding leading to transfusion of blood(3 year)
- • Mortality.(3 year)
- • Time to drain removal.(3 year)
- • Length of stay in hospital.(3 year)
- • Surgery time.(3 year)
- • Percentage of patients developing post operative bleeding leading to re-operation.(3 year)
- • Percentage of patients developing post operative biliary leaking.(3 year)
研究者
研究点 (2)
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