HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children (HemORL)
23 april 2018 uppdaterad av: 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
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
74
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Isère
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Grenoble, Isère, Frankrike, 38043
- Rekrytering
- University Hospital, Grenoble
-
Kontakt:
- Emilie Chipon
-
Underutredare:
- Alice Hitter, MD
-
Underutredare:
- Anne Rivron, MD
-
Underutredare:
- Jean-Pierre Alibeu, MD
-
Underutredare:
- Elea Lamblin, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 år till 10 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Andra namn:
|
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Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of the vacuum device hemostatic technique at his installation on the wound
Tidsram: From the beginning to the end of a tonsillectomy: an expected average of 2 hours
|
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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
Tidsram: 10 days
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Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)
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10 days
|
|
Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group
Tidsram: Time between general anesthesia and discharge hospitalization: an average of one day
|
Time between general anesthesia and first complaint of pain
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Time between general anesthesia and discharge hospitalization: an average of one day
|
|
Comparison of surgery time between the 2 arm
Tidsram: 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)
Tidsram: Until 11 days after surgery
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Time or/and day of the first meal without pain
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Until 11 days after surgery
|
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Comparison between the 2 arms of the number of primary hemorrhages
Tidsram: Until 24 hours after surgery
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Number of primary hemorrhages
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Until 24 hours after surgery
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Comparison between the 2 arms of the number of secondary hemorrhages
Tidsram: From 24 hours after surgery until 11 days after surgery
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Number of secondary hemorrhages
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From 24 hours after surgery until 11 days after surgery
|
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Comparison between the 2 arms of the number of rehospitalisation (all circumstances)
Tidsram: From 24 hours after surgery until 11 days after surgery
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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
Tidsram: Until 11 days after surgery
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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).
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Until 11 days after surgery
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Clinician evaluation about the feasibility of the vacuum device installation
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sébastien Schmerber, MD, PhD, University Hospital, Grenoble
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2014
Primärt slutförande (Förväntat)
1 september 2018
Avslutad studie (Förväntat)
1 februari 2019
Studieregistreringsdatum
Först inskickad
5 juli 2013
Först inskickad som uppfyllde QC-kriterierna
17 juli 2013
Första postat (Uppskatta)
22 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2018
Senast verifierad
1 april 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HemORL-DCIC-1211
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