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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01904461
First received: July 5, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention
Tonsillectomy
Hemorrhage
Postoperative Complications
Device: Vacuum device
Procedure: Conventional surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Comparison of cauterization time to obtain the tonsillectomy wounds hemostaesis 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 ] [ Designated as safety issue: No ]
    Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostaesis using bipolar forceps(electric power of 20W)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • Number of success or failure to install the device
    • Cases of no immediately hemostasis

  • Assessment between two arm of the postoperative pain until 10 days after the surgery [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 15 years old)

  • 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 ] [ Designated as safety issue: No ]
    Time between general anesthesia and first complaint of pain

  • Comparison of surgery time between the 2 arm [ Time Frame: An expected average of 2 hours ] [ Designated as safety issue: No ]
    Time between the first incision and final wounds hemostasis verification

  • Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids) [ Time Frame: Until 11 days after surgery ] [ Designated as safety issue: No ]
    Time or/and day of the first meal without pain

  • Comparison between the 2 arms of the number of primary hemorrhages [ Time Frame: Until 24 hours after surgery ] [ Designated as safety issue: No ]
    Number of primary hemorrhages

  • Comparison between the 2 arms of the number of secondary hemorrhages [ Time Frame: From 24 hours after surgery until 11 days after surgery ] [ Designated as safety issue: No ]
    Number of secondary hemorrhages

  • Comparison between the 2 arms of the number of rehozpitalisation (all circumstances) [ Time Frame: From 24 hours after surgery until 11 days after surgery ] [ Designated as safety issue: No ]
    Number of rehozpitalisation

  • Comparison between the 2 arms of the number of strong analgesics doses [ Time Frame: Until 11 days after surgery ] [ Designated as safety issue: No ]
    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 15 years old).

  • 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 ] [ Designated as safety issue: No ]
    Score from a qualitative satisfaction scale


Estimated Enrollment: 74
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children from 3 to 15 years old undergoing tonsillectomy (with or without adenoidectomy)
  • children without 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 L1121-5 and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904461

Locations
France
University Hospital, Grenoble
Grenoble, Isère, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Sébastien Schmerber, MD, PhD University Hospital, Grenoble
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01904461     History of Changes
Other Study ID Numbers: HemORL-DCIC-1211
Study First Received: July 5, 2013
Last Updated: April 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
tonsillectomy
children
vacuum
medical device
pain
hemorrhage
post-surgical complications

Additional relevant MeSH terms:
Hemorrhage
Postoperative Complications
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014