NCT02853695

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

July 19, 2016

Last Update Submit

July 19, 2019

Conditions

HysteroscopyMinimally Invasive Surgical ProceduresPolypMyomaUterine SeptumPlacental RemnantAdhesiolysis

Keywords

HysteroscopyDiffusionImplementationDiagnostic hysteroscopyOperative hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Questionnaire: setting for performing diagnostic hysteroscopy

    August 2016, questionnaire will be sent once at the start of the study

  • Questionnaire:Instrumentation used for hysteroscopy

    August 2016, questionnaire will be sent once at the start of the study

  • Questionnaire: Diagnostic and techniques in the treatment of intrauterine pathology

    August 2016, questionnaire will be sent once at the start of the study

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recognized gynaecologists (members of the Flemisch Society of Obstetricians and Gyneacologists (VVOG) and members of the Dutch Society of Obstetricians and Gyneacologists (NVOG))

You may qualify if:

  • gynaecologist

You may not qualify if:

  • residents in training for gynaecology/obstetrics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 20349076BACKGROUND

  • 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: 17630157BACKGROUND

  • 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: 17629392BACKGROUND

  • 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: 16737769BACKGROUND

  • 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.

    PMID: 23434402BACKGROUND

MeSH Terms

Conditions

PolypsMyomaSeptate Uterus

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine Duplication AnomaliesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tjalina Hamerlynck

    Ghent University Hostpital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 3, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 22, 2019

Record last verified: 2019-07