Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results
NCT ID: NCT05337605
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
87 participants
OBSERVATIONAL
2022-04-01
2022-11-08
Brief Summary
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The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.
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Detailed Description
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* Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other.
* Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
* Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in the REMOvE9 study.
* Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hand driven tissue removal system
Endometrial polyp removed by hysteroscopic hand-driven tissue removal system in a previous study.
No interventions assigned to this group
Motor driven tissue removal system
Endometrial polyp removed by hysteroscopic motor-driven tissue removal system in a previous study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Tjalina Hamerlynck, Md, Phd
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Countries
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References
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Van Geyte M, de Frenne A, Weyers B, Weyers S, van Vliet H, Hamerlynck T, van Wessel S. Manually driven versus motor driven hysteroscopic tissue removal system for polypectomy: Long-term results. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:270-274. doi: 10.1016/j.ejogrb.2024.03.013. Epub 2024 Mar 12.
Other Identifiers
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BC-11626 BC-11627 BC-11628
Identifier Type: -
Identifier Source: org_study_id
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