Randomized, Double-blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- conversion rate
研究概览
简要总结
In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent and common bile duct lesions.
The HARMONIC SCALPEL® (H) is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation.
H technology reduces the need for ligatures with simultaneous cutting and coagulation: moreover there is not electricity to or through the patient H has a greater precision near vital structures and it produces minimal smoke with improved visibility in the surgical field.
In retrospective series LC performed with H was demonstrated feasible and effective with minimal operating time and blood loss: it was reported also a low conversion rate (3.9%).
However there are not prospective randomized controlled trials showing the advantages of H compared to MD (the commonly used electrical scalpel) in LC.
Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for AC.
详细描述
DESIGN
The study project is a prospective, randomized investigation. The study will be performed in the Department of Emergency Surgery St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institutions, with the participation of all surgeons who accept to be involved in.
The patients will be divided in two groups: in the first group the patient will be submitted to early LC within 72 hours after the diagnosis with H while in the second group will be submitted to early LC within 72 hours with MD.
HOW RANDOMIZED
The randomization will be obtained through computer-generated schedule. The result of this randomization will be sealed in numbered envelopes. After cholecystitis diagnosis if the patient fulfils the inclusion criteria the responsible surgeon will ask the patient to participate to the study. If the patient agree, he/ she will sign the informed consent. After patient's consent the randomization will be carried out. The responsible surgeon will record the patient name (and number).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years)
- •Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of cholecystitis
- •ASA I-III patients
- •Informed consent
- •Less than 72h from the onset
排除标准
- •Informed consent refusal
- •Choledocholithiasis
- •Generalized peritonitis
- •Previous abdominal surgical procedures
- •Patients with an intra-operative findings of different pathology will be excluded from the study
- •Apache II score > 10
结局指标
主要结局
conversion rate
时间窗: 1 day
operative time
时间窗: 1 day
mortality
时间窗: 6-months
morbidity
时间窗: 6-months
hospital stay
时间窗: at discharge
postoperative pain
时间窗: postoperatively
return to daily activities
时间窗: 6-months
次要结局
未报告次要终点