Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-04-15 @ 8:07 PM
Study NCT ID:
NCT01904461
Status:
UNKNOWN
Last Update Posted:
2018-04-25
First Post:
2013-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-23', 'studyFirstSubmitDate': '2013-07-05', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group', 'timeFrame': 'From the beginning to the end of a tonsillectomy: an expected average of 2 hours', 'description': 'Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W)'}], 'secondaryOutcomes': [{'measure': 'Assessment of the vacuum device hemostatic technique at his installation on the wound', 'timeFrame': 'From the beginning to the end of a tonsillectomy: an expected average of 2 hours', 'description': '* Number of success or failure to install the device\n* Cases of no immediately hemostasis'}, {'measure': 'Assessment between two arm of the postoperative pain until 10 days after the surgery', 'timeFrame': '10 days', 'description': 'Pain score every day (FLACC -\\> children between 3 and 7 years old Faces pain scale -\\> children between 8 and 10 years old)'}, {'measure': 'Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group', 'timeFrame': 'Time between general anesthesia and discharge hospitalization: an average of one day', 'description': 'Time between general anesthesia and first complaint of pain'}, {'measure': 'Comparison of surgery time between the 2 arm', 'timeFrame': 'An expected average of 2 hours', 'description': 'Time between the first incision and final wounds hemostasis verification'}, {'measure': 'Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids)', 'timeFrame': 'Until 11 days after surgery', 'description': 'Time or/and day of the first meal without pain'}, {'measure': 'Comparison between the 2 arms of the number of primary hemorrhages', 'timeFrame': 'Until 24 hours after surgery', 'description': 'Number of primary hemorrhages'}, {'measure': 'Comparison between the 2 arms of the number of secondary hemorrhages', 'timeFrame': 'From 24 hours after surgery until 11 days after surgery', 'description': 'Number of secondary hemorrhages'}, {'measure': 'Comparison between the 2 arms of the number of rehospitalisation (all circumstances)', 'timeFrame': 'From 24 hours after surgery until 11 days after surgery', 'description': 'Number of rehospitalisation'}, {'measure': 'Comparison between the 2 arms of the number of strong analgesics doses', 'timeFrame': 'Until 11 days after surgery', 'description': '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).'}, {'measure': 'Clinician evaluation about the feasibility of the vacuum device installation', 'timeFrame': 'From the beginning to the end of a tonsillectomy: an expected average of 2 hours', 'description': 'Score from a qualitative satisfaction scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tonsillectomy', 'children', 'vacuum', 'medical device', 'pain', 'hemorrhage', 'post-surgical complications'], 'conditions': ['Tonsillectomy', 'Hemorrhage', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '21075003', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22334630', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22566511', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.cic-it-grenoble.fr/', 'label': 'Website of the Grenoble clinical investigation center - Technological Innovation'}]}, 'descriptionModule': {'briefSummary': 'The long-term objective of this study is to prove:\n\n* the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the number of secondary hemorrhages\n* the decrease of pain and quicker re-feeding\n* an easier haemostasis\n* the simplification of the tonsillectomy surgical kit\n* the decrease of dissection time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children from 3 to 10 years old undergoing tonsillectomy (with or without adenoidectomy)\n* children without known hemophilia or any coagulation trouble\n* children speaking and understanding French\n* children's both parents must speak and understand French\n* children's both parents must be affiliate to social security or similarly regime\n\nExclusion Criteria:\n\n* children with known allergy to silicone\n* refusal to consent: from child's age to consent or from both parents\n* telephone monitoring refusal\n* protected person referred to in Articles L1121-6 of the Code of Public Health\n* children's both parents are protected persons referred to in Articles L1121-8 of the Code of Public Health"}, 'identificationModule': {'nctId': 'NCT01904461', 'acronym': 'HemORL', 'briefTitle': 'HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children', 'orgStudyIdInfo': {'id': 'HemORL-DCIC-1211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vacuum device surgery', 'description': 'At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis', 'interventionNames': ['Device: Vacuum device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional surgery', 'description': 'At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis', 'interventionNames': ['Procedure: Conventional surgery']}], 'interventions': [{'name': 'Vacuum device', 'type': 'DEVICE', 'otherNames': ['-Suction cup', '-Redon 600ml'], 'armGroupLabels': ['Vacuum device surgery']}, {'name': 'Conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Conventional surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Isère', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Chipon', 'role': 'CONTACT'}, {'name': 'Alice Hitter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Rivron, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Pierre Alibeu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elea Lamblin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital, Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Sébastien Schmerber, MD,PhD', 'role': 'CONTACT', 'email': 'Echipon@chu-grenoble.fr'}, {'name': 'Alexandre Moreau-Gaudry, MD, PhD', 'role': 'CONTACT', 'email': 'Echipon@chu-grenoble.fr'}], 'overallOfficials': [{'name': 'Sébastien Schmerber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'HEMOSQUID', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}