- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853695
Implementation of Hysteroscopy in Flanders and the Netherlands
Study Overview
Status
Detailed Description
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).
The 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.
The 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.
The 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.
An 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- gynaecologist
Exclusion Criteria:
- residents in training for gynaecology/obstetrics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire: Implementation of hysteroscopy
Time Frame: August 2016, questionnaire will be sent once at the start of the study
|
the amount of gynaecologists performing hysteroscopy in relation to the total of gynaecologists participating in the questionnaire
|
August 2016, questionnaire will be sent once at the start of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire: setting for performing diagnostic hysteroscopy
Time Frame: August 2016, questionnaire will be sent once at the start of the study
|
in which setting (office/operating room) diagnostic hysteroscopies are performed in relation to the total amount of diagnostic hysteroscopies performed
|
August 2016, questionnaire will be sent once at the start of the study
|
|
Questionnaire:Instrumentation used for hysteroscopy
Time Frame: August 2016, questionnaire will be sent once at the start of the study
|
which instrumentation is used for specific hysteroscopic procedures.
|
August 2016, questionnaire will be sent once at the start of the study
|
|
Questionnaire: Diagnostic and techniques in the treatment of intrauterine pathology
Time Frame: August 2016, questionnaire will be sent once at the start of the study
|
which diagnostics and techniques are used in the treatment of intrauterine pathology
|
August 2016, questionnaire will be sent once at the start of the study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Tjalina Hamerlynck, Ghent University Hostpital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B670201628466
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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