Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluate the reduction in morphine consumption
研究概览
简要总结
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .
In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.
详细描述
Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:
The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.
In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min).
The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.
A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).
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
- None
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
- •over 18 years
- •with indication of hernia repair
- •a collar with a diameter of less than 10cm
- •no antecedent of hernia treatment with poses plate
- •agreeing coelioscopy
- •agreeing to participate the clinical study, having sign an informed consent
- •agreeing a regular monitor
排除标准
- •taking analgesic tier 2 or 3
- •against indication to anesthetics or coelioscopy
- •creatinine clearance less than 30 ml/min
- •pregnant woman and protected persons
- •no affiliation to social security
- •unable to understand the information form
研究组 & 干预措施
1
robot-assisted coelioscopy
干预措施: Laparoscopic DA VINCI Robot Assisted coelioscopy (Device)
2
conventional coelioscopy
干预措施: conventional coelioscopy (Procedure)
结局指标
主要结局
Evaluate the reduction in morphine consumption
时间窗: during the postoperative 48h
次要结局
- morbidity(during the study)
- Pain patient (ENS, total consumption of morphine)(during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery)
- length of stay in hospital, percentage return home to 24 hours of surgery(to 24 hours of surgery)
- resumption of work(after surgery)
- quality of life (questionary SF-36)(1 month, 6 month and 12 month of surgery)