Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02853695
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2016-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Hysteroscopy in Flanders and the Netherlands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}, {'id': 'D009214', 'term': 'Myoma'}, {'id': 'D000093665', 'term': 'Septate Uterus'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000093662', 'term': 'Uterine Duplication Anomalies'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-19', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire: Implementation of hysteroscopy', 'timeFrame': 'August 2016, questionnaire will be sent once at the start of the study', 'description': 'the amount of gynaecologists performing hysteroscopy in relation to the total of gynaecologists participating in the questionnaire'}], 'secondaryOutcomes': [{'measure': 'Questionnaire: setting for performing diagnostic hysteroscopy', 'timeFrame': 'August 2016, questionnaire will be sent once at the start of the study', 'description': 'in which setting (office/operating room) diagnostic hysteroscopies are performed in relation to the total amount of diagnostic hysteroscopies performed'}, {'measure': 'Questionnaire:Instrumentation used for hysteroscopy', 'timeFrame': 'August 2016, questionnaire will be sent once at the start of the study', 'description': 'which instrumentation is used for specific hysteroscopic procedures.'}, {'measure': 'Questionnaire: Diagnostic and techniques in the treatment of intrauterine pathology', 'timeFrame': 'August 2016, questionnaire will be sent once at the start of the study', 'description': 'which diagnostics and techniques are used in the treatment of intrauterine pathology'}]}, 'conditionsModule': {'keywords': ['Hysteroscopy', 'Diffusion', 'Implementation', 'Diagnostic hysteroscopy', 'Operative hysteroscopy'], 'conditions': ['Hysteroscopy', 'Minimally Invasive Surgical Procedures', 'Polyp', 'Myoma', 'Uterine Septum', 'Placental Remnant', 'Adhesiolysis']}, 'referencesModule': {'references': [{'pmid': '20349076', 'type': 'BACKGROUND', 'citation': 'Siristatidis C, Chrelias C, Salamalekis G, Kassanos D. Office hysteroscopy: current trends and potential applications: a critical review. Arch Gynecol Obstet. 2010 Oct;282(4):383-8. doi: 10.1007/s00404-010-1437-x. Epub 2010 Mar 27.'}, {'pmid': '17630157', 'type': 'BACKGROUND', 'citation': 'Valle RF. Development of hysteroscopy: from a dream to a reality, and its linkage to the present and future. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):407-18. doi: 10.1016/j.jmig.2007.03.002.'}, {'pmid': '17629392', 'type': 'BACKGROUND', 'citation': 'Timmermans A, van Dongen H, Mol BW, Veersema S, Jansen FW. Hysteroscopy and removal of endometrial polyps: a Dutch survey. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):76-9. doi: 10.1016/j.ejogrb.2007.05.016. Epub 2007 Jul 12.'}, {'pmid': '16737769', 'type': 'BACKGROUND', 'citation': 'van Dongen H, Kolkman W, Jansen FW. Implementation of hysteroscopic surgery in The Netherlands. Eur J Obstet Gynecol Reprod Biol. 2007 Jun;132(2):232-6. doi: 10.1016/j.ejogrb.2006.04.016. Epub 2006 Jun 5.'}, {'pmid': '23434402', 'type': 'BACKGROUND', 'citation': 'Pascual-Pedreno A, Perez-Medina T, Brouard Urkiaga I, Fernandez-Parra J, Sobreviela-Laserrada M. Practice of endoscopic gynecologic surgery: a survey of Spanish gynecologists. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(1):64-8. doi: 10.1016/j.ejogrb.2013.01.017. Epub 2013 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands', 'detailedDescription': "Hysteroscopy is a minimally invasive method for diagnosis and treatment of intra-uterine abnormalities. Complication and failure rates are low because of the direct visualisation of the treated abnormality. Moreover, hysteroscopic procedures replaced 'blind' (curettage) and more invasive interventions (hysterectomy).\n\nThe field of hysteroscopy has developed over the years. Changes occurred in hysteroscopic instruments and in the use of energy sources. An important development is the smaller diameter of the hysteroscopic system which makes it suitable for an outpatient setting. Not every gynaecologist, however, has the appropriate hysteroscopic skills or setting to carry out these procedures.\n\nThe incorporation of hysteroscopic procedures into daily practice in Flanders is unclear. In the Netherlands 2 surveys were conducted in the past to question the treatment options for polypectomy in an outpatient setting on the one hand and the diffusion of hysteroscopy on the other hand.\n\nThe investigators want to study the diffusion of hysteroscopy in Flanders and the Netherlands. Moreover the investigators want to provide an overview of the hysteroscopic procedures implemented, as well as the setting they are performed in.\n\nAn electronic questionnaire (LimeService) will be sent to all gynaecologists in Flanders and the Netherlands. Participation is voluntary and anonymous. After informed consent all gynaecologists are asked to complete the first part of the questionnaire containing general information. The second part is specific for gynaecologists performing hysteroscopy themselves, and inquires about the procedures they carry out."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recognized gynaecologists (members of the Flemisch Society of Obstetricians and Gyneacologists (VVOG) and members of the Dutch Society of Obstetricians and Gyneacologists (NVOG))', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gynaecologist\n\nExclusion Criteria:\n\n* residents in training for gynaecology/obstetrics'}, 'identificationModule': {'nctId': 'NCT02853695', 'briefTitle': 'Implementation of Hysteroscopy in Flanders and the Netherlands', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Implementation of Hysteroscopy in Flanders and the Netherlands', 'orgStudyIdInfo': {'id': 'B670201628466'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tjalina Hamerlynck', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ghent University Hostpital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Society of Obstetricians and Gyneacologists (NVOG)', 'class': 'UNKNOWN'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Vlaamse Vereniging voor Obstetrie en Gynaecologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}