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

April 23, 2018 updated by: 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • Recruiting
        • University Hospital, Grenoble
        • Contact:
          • Emilie Chipon
        • Sub-Investigator:
          • Alice Hitter, MD
        • Sub-Investigator:
          • Anne Rivron, MD
        • Sub-Investigator:
          • Jean-Pierre Alibeu, MD
        • Sub-Investigator:
          • Elea Lamblin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 600ml
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the beginning to the end of a tonsillectomy: an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
10 days
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
Time between general anesthesia and discharge hospitalization: an average of one day
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
An expected average of 2 hours
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
Until 11 days after surgery
Comparison between the 2 arms of the number of primary hemorrhages
Time Frame: Until 24 hours after surgery
Number of primary hemorrhages
Until 24 hours after surgery
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
From 24 hours after surgery until 11 days after surgery
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
From 24 hours after surgery until 11 days after surgery
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).
Until 11 days after surgery
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
From the beginning to the end of a tonsillectomy: an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

HEMOSQUID

Investigators

  • Principal Investigator: Sébastien Schmerber, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HemORL-DCIC-1211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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