NCT01904461Unknown不适用
Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
研究概览
简要总结
The long-term objective of this study is to prove:
- the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the number of secondary hemorrhages
- the decrease of pain and quicker re-feeding
- an easier haemostasis
- the simplification of the tonsillectomy surgical kit
- the decrease of dissection time
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children from 3 to 10 years old undergoing tonsillectomy (with or without adenoidectomy)
- •children without known hemophilia or any coagulation trouble
- •children speaking and understanding French
- •children's both parents must speak and understand French
- •children's both parents must be affiliate to social security or similarly regime
排除标准
- •children with known allergy to silicone
- •refusal to consent: from child's age to consent or from both parents
- •telephone monitoring refusal
- •protected person referred to in Articles L1121-6 of the Code of Public Health
- •children's both parents are protected persons referred to in Articles L1121-8 of the Code of Public Health
研究组 & 干预措施
Vacuum device surgery
Experimental
At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis
干预措施: Vacuum device (Device)
Conventional surgery
Active Comparator
At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
干预措施: Conventional surgery (Procedure)
结局指标
主要结局
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
时间窗: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W)
次要结局
- Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)(Until 11 days after surgery)
- Comparison between the 2 arms of the number of primary hemorrhages(Until 24 hours after surgery)
- Comparison between the 2 arms of the number of strong analgesics doses(Until 11 days after surgery)
- Comparison between the 2 arms of the number of rehospitalisation (all circumstances)(From 24 hours after surgery until 11 days after surgery)
- Assessment between two arm of the postoperative pain until 10 days after the surgery(10 days)
- Comparison of surgery time between the 2 arm(An expected average of 2 hours)
- Assessment of the vacuum device hemostatic technique at his installation on the wound(From the beginning to the end of a tonsillectomy: an expected average of 2 hours)
- Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group(Time between general anesthesia and discharge hospitalization: an average of one day)
- Comparison between the 2 arms of the number of secondary hemorrhages(From 24 hours after surgery until 11 days after surgery)
- Clinician evaluation about the feasibility of the vacuum device installation(From the beginning to the end of a tonsillectomy: an expected average of 2 hours)
研究者
研究点 (1)
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