HysteroscopyNCT02853695
Implementation of Hysteroscopy in Flanders and the Netherlands
An observational study of Hysteroscopy and Minimally Invasive Surgical Procedures, run by University Ghent.
Trial summary
By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy, Minimally Invasive Surgical Procedures, Polyp
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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))
Who may be able to join
- gynaecologist
Who cannot join
- residents in training for gynaecology/obstetrics
About this study
By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands
Read the 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.
- Conditions
- Hysteroscopy, Minimally Invasive Surgical Procedures, Polyp, Myoma, Uterine Septum, Placental Remnant
- Keywords
- Hysteroscopy, Diffusion, Implementation, Diagnostic hysteroscopy, Operative hysteroscopy
- Medical subject headings
- Polyps, Myoma, Septate Uterus
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire: Implementation of hysteroscopy
the amount of gynaecologists performing hysteroscopy in relation to the total of gynaecologists participating in the questionnaire
Measured: August 2016, questionnaire will be sent once at the start of the study
Secondary outcomes (3)
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
Measured: August 2016, questionnaire will be sent once at the start of the study
Questionnaire:Instrumentation used for hysteroscopy
which instrumentation is used for specific hysteroscopic procedures.
Measured: August 2016, questionnaire will be sent once at the start of the study
Questionnaire: Diagnostic and techniques in the treatment of intrauterine pathology
which diagnostics and techniques are used in the treatment of intrauterine pathology
Measured: August 2016, questionnaire will be sent once at the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Society of Obstetricians and Gyneacologists (NVOG), Catharina Ziekenhuis Eindhoven, Vlaamse Vereniging voor Obstetrie en Gynaecologie
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, Study director, Ghent University Hostpital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853695
- Sponsor's protocol ID
- B670201628466
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
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.
PubMed 20349076Valle 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.
PubMed 17630157Timmermans 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.
PubMed 17629392van 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.
PubMed 16737769Pascual-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.
PubMed 23434402
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Hysteroscopy in Flanders and the Netherlands
- ClinicalTrials.gov ID
- NCT02853695
- Acronym / sponsor ID
- B670201628466
- Conditions
- Hysteroscopy, Minimally Invasive Surgical Procedures, Polyp, Myoma, Uterine Septum, Placental Remnant
- Keywords
- Hysteroscopy, Diffusion, Implementation, Diagnostic hysteroscopy, Operative hysteroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Dutch Society of Obstetricians and Gyneacologists (NVOG), Catharina Ziekenhuis Eindhoven, Vlaamse Vereniging voor Obstetrie en Gynaecologie
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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))
Key inclusion criteria (1 listed)
- gynaecologist
Key exclusion criteria (1 listed)
- residents in training for gynaecology/obstetrics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Questionnaire: setting for performing diagnostic hysteroscopy
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Background: PubMed 20349076Siristatidis 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.
- Background: PubMed 17630157Valle 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.
- Background: PubMed 17629392Timmermans 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.
- Background: PubMed 16737769van 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.
- Background: PubMed 23434402Pascual-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjalina Hamerlynck study director
Ghent University Hostpital
Questions about this trial
What is this clinical trial studying?
An observational study of Hysteroscopy and Minimally Invasive Surgical Procedures, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire: Implementation of hysteroscopy (time frame: August 2016, questionnaire will be sent once at the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853695, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.