Implementation of Hysteroscopy in Flanders and the Netherlands

Hysteroscopy Clinical Trial

Official title:

Implementation of Hysteroscopy in Flanders and the Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853695
• Other study ID #: B670201628466
• Status: Completed
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• gynaecologist

Exclusion Criteria:

• residents in training for gynaecology/obstetrics

Related Conditions & MeSH terms

• Adhesiolysis
• Hysteroscopy
• Minimally Invasive Surgical Procedures
• Myoma
• Placental Remnant
• Polyp
• Uterine Septum

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Catharina Ziekenhuis Eindhoven, Dutch Society of Obstetricians and Gyneacologists (NVOG), Vlaamse Vereniging voor Obstetrie en Gynaecologie

References & Publications (5)

Pascual-Pedreño A, Perez-Medina T, Brouard Urkiaga I, Fernández-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. — View 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. Review. — View 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. Epub 2007 Jul 12. — View 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. Review. — View 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. Epub 2006 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire: Implementation of hysteroscopy	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	Questionnaire: setting for performing diagnostic hysteroscopy	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
Secondary	Questionnaire:Instrumentation used for hysteroscopy	which instrumentation is used for specific hysteroscopic procedures.	August 2016, questionnaire will be sent once at the start of the study
Secondary	Questionnaire: Diagnostic and techniques in the treatment of intrauterine pathology	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