HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children (HemORL)
2018年4月23日 更新者：University Hospital, Grenoble
Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
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
研究概览
研究类型
介入性
注册 (预期的)
74
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Isère
-
Grenoble、Isère、法国、38043
- 招聘中
- University Hospital, Grenoble
-
接触：
- Emilie Chipon
-
副研究员：
- Alice Hitter, MD
-
副研究员：
- Anne Rivron, MD
-
副研究员：
- Jean-Pierre Alibeu, MD
-
副研究员：
- Elea Lamblin, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 10年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Vacuum device surgery
At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis
|
其他名称：
|
|
有源比较器：Conventional surgery
At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
大体时间：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)
|
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of the vacuum device hemostatic technique at his installation on the wound
大体时间：From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
|
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
|
Assessment between two arm of the postoperative pain until 10 days after the surgery
大体时间：10 days
|
Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)
|
10 days
|
|
Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
大体时间：Time between general anesthesia and discharge hospitalization: an average of one day
|
Time between general anesthesia and first complaint of pain
|
Time between general anesthesia and discharge hospitalization: an average of one day
|
|
Comparison of surgery time between the 2 arm
大体时间：An expected average of 2 hours
|
Time between the first incision and final wounds hemostasis verification
|
An expected average of 2 hours
|
|
Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)
大体时间：Until 11 days after surgery
|
Time or/and day of the first meal without pain
|
Until 11 days after surgery
|
|
Comparison between the 2 arms of the number of primary hemorrhages
大体时间：Until 24 hours after surgery
|
Number of primary hemorrhages
|
Until 24 hours after surgery
|
|
Comparison between the 2 arms of the number of secondary hemorrhages
大体时间：From 24 hours after surgery until 11 days after surgery
|
Number of secondary hemorrhages
|
From 24 hours after surgery until 11 days after surgery
|
|
Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
大体时间：From 24 hours after surgery until 11 days after surgery
|
Number of rehospitalisation
|
From 24 hours after surgery until 11 days after surgery
|
|
Comparison between the 2 arms of the number of strong analgesics doses
大体时间：Until 11 days after surgery
|
Number of strong analgesics doses per day.
Strong analgesics are used only if the child has a FLACC score higher than 3 (children from 3 to 7 years old) and a Faces Pain Scale score higher than 4 (children from 8 to 10 years old).
|
Until 11 days after surgery
|
|
Clinician evaluation about the feasibility of the vacuum device installation
大体时间：From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
Score from a qualitative satisfaction scale
|
From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Sébastien Schmerber, MD, PhD、University Hospital, Grenoble
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Guerrero K, Moreau-Gaudry A, Porcu P, Blin D. An innovative technique to control bleeding with vacuum device. Eur J Cardiothorac Surg. 2011 Jun;39(6):1070-2. doi: 10.1016/j.ejcts.2010.09.047. Epub 2010 Nov 12.
- Brichon PY, Porcu P, Moreau-Gaudry A, Blin D. Extraction of substernal goitre using an innovative vacuum device. Eur J Cardiothorac Surg. 2012 Jul;42(1):178-9. doi: 10.1093/ejcts/ezs018. Epub 2012 Feb 13.
- Porcu P, Moreau-Gaudry A, Chavanon O, Blin D. Haemostasis of a right ventricle-gunshot wound using a novel haemostatic vacuum device. Interact Cardiovasc Thorac Surg. 2012 Aug;15(2):294-6. doi: 10.1093/icvts/ivs103. Epub 2012 May 7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年10月1日
初级完成 (预期的)
2018年9月1日
研究完成 (预期的)
2019年2月1日
研究注册日期
首次提交
2013年7月5日
首先提交符合 QC 标准的
2013年7月17日
首次发布 (估计)
2013年7月22日
研究记录更新
最后更新发布 (实际的)
2018年4月25日
上次提交的符合 QC 标准的更新
2018年4月23日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.