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Clinical Trials/NCT01904461
NCT01904461UnknownNot Applicable

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

University Hospital, Grenoble1 site in 1 country74 target enrollmentStarted: October 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
3 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Vacuum device surgery

Experimental

At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis

Intervention: Vacuum device (Device)

Conventional surgery

Active Comparator

At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis

Intervention: Conventional surgery (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

  • Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)(Until 11 days after surgery)
  • Comparison between the 2 arms of the number of primary hemorrhages(Until 24 hours after surgery)
  • Comparison between the 2 arms of the number of strong analgesics doses(Until 11 days after surgery)
  • Comparison between the 2 arms of the number of rehospitalisation (all circumstances)(From 24 hours after surgery until 11 days after surgery)
  • Assessment between two arm of the postoperative pain until 10 days after the surgery(10 days)
  • Comparison of surgery time between the 2 arm(An expected average of 2 hours)
  • Assessment of the vacuum device hemostatic technique at his installation on the wound(From the beginning to the end of a tonsillectomy: an expected average of 2 hours)
  • Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group(Time between general anesthesia and discharge hospitalization: an average of one day)
  • Comparison between the 2 arms of the number of secondary hemorrhages(From 24 hours after surgery until 11 days after surgery)
  • Clinician evaluation about the feasibility of the vacuum device installation(From the beginning to the end of a tonsillectomy: an expected average of 2 hours)

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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