HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device Dur… (NCT01904461) | Clinical Trial Compass
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HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
France74 participantsStarted 2014-10
Plain-language summary
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
Who can participate
Age range
3 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Timeframe: From the beginning to the end of a tonsillectomy: an expected average of 2 hours