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HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children (HemORL)

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ClinicalTrials.gov Identifier: NCT01904461
Recruitment Status : Recruiting
First Posted : July 22, 2013
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
HEMOSQUID
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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

Condition or disease Intervention/treatment Phase
Tonsillectomy Hemorrhage Postoperative Complications Device: Vacuum device Procedure: Conventional surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Device: Vacuum device
Other Names:
  • -Suction cup
  • -Redon Drainobag®600
Active Comparator: 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
Procedure: Conventional surgery



Primary Outcome Measures :
  1. Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group [ Time Frame: 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)


Secondary Outcome Measures :
  1. Assessment of the vacuum device hemostatic technique at his installation on the wound [ Time Frame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours ]
    • Number of success or failure to install the device
    • Cases of no immediately hemostasis

  2. Assessment between two arm of the postoperative pain until 10 days after the surgery [ Time Frame: 10 days ]
    Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old)

  3. Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group [ Time Frame: Time between general anesthesia and discharge hospitalization: an average of one day ]
    Time between general anesthesia and first complaint of pain

  4. Comparison of surgery time between the 2 arm [ Time Frame: An expected average of 2 hours ]
    Time between the first incision and final wounds hemostasis verification

  5. Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids) [ Time Frame: Until 11 days after surgery ]
    Time or/and day of the first meal without pain

  6. Comparison between the 2 arms of the number of primary hemorrhages [ Time Frame: Until 24 hours after surgery ]
    Number of primary hemorrhages

  7. Comparison between the 2 arms of the number of secondary hemorrhages [ Time Frame: From 24 hours after surgery until 11 days after surgery ]
    Number of secondary hemorrhages

  8. Comparison between the 2 arms of the number of rehospitalisation (all circumstances) [ Time Frame: From 24 hours after surgery until 11 days after surgery ]
    Number of rehospitalisation

  9. Comparison between the 2 arms of the number of strong analgesics doses [ Time Frame: 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).

  10. Clinician evaluation about the feasibility of the vacuum device installation [ Time Frame: From the beginning to the end of a tonsillectomy: an expected average of 2 hours ]
    Score from a qualitative satisfaction scale



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904461


Contacts
Contact: Sébastien Schmerber, MD,PhD Echipon@chu-grenoble.fr
Contact: Alexandre Moreau-Gaudry, MD, PhD Echipon@chu-grenoble.fr

Locations
France
University Hospital, Grenoble Recruiting
Grenoble, Isère, France, 38043
Contact: Emilie Chipon         
Sub-Investigator: Alice Hitter, MD         
Sub-Investigator: Anne Rivron, MD         
Sub-Investigator: Jean-Pierre Alibeu, MD         
Sub-Investigator: Elea Lamblin, MD         
Sponsors and Collaborators
University Hospital, Grenoble
HEMOSQUID
Investigators
Principal Investigator: Sébastien Schmerber, MD, PhD University Hospital, Grenoble