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Clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr™ 5fr, for the resection of endometrial polyps in an office setting

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

A first clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr™ 5fr, for office polypectomy without any anesthesia.

Methods

Women with at least one small endometrial polyp were eligible. Hysteroscopic polypectomy was performed using the Resectr™ 5fr in an office setting, without any anesthesia.

Results

One hundred and two hysteroscopic polypectomies were included in the analysis. The median installation time was 1.9 min (95% confidence interval (CI) 1.6–2.1). The median time to complete polyp removal was 1.2 min (95% CI 0.8–1.6). The median surgeon’s safety, practical, and comfort scores on a 5-point Likert scale were high (5 (5–5), 5 (4–5), and 5 (4–5), respectively). Women’s pain score was low (median 1 (0–3)), whereas the satisfaction rate was high (median 5 (5–5)), both on a 5-point Likert scale. There were two conversions (hysteroscopic scissors (n = 1), a new Resectr™ 5fr device (n = 1)). There was one incomplete procedure (tissue hardness).

Conclusion

Hysteroscopic removal of small polyps, using the \({Resectr}^{TM}\) 5fr in an office setting is feasible in terms of installation and resection time. Surgeon’s practical, comfort, and safety scores are high, whereas women report low pain scores and high satisfaction rates. 

Trial registration

Dutch Clinical Trial Registry (NTR 7119, NL6923): https://www.trialregister.nl/trial/6923. Date of registration: 27/03/2018.

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Data availability

Data available on request due to privacy/ethical restrictions.

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Acknowledgements

Unrestricted grant from Boston Scientific.

Funding

Unrestricted grant from Boston Scientific.

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Authors and Affiliations

  1. Women’s Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium

    Steffi van Wessel, Tjalina Hamerlynck, Huib van Vliet, Steven Weyers & Benedictus Schoot

  2. Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands

    Huib van Vliet & Benedictus Schoot

Authors
  1. Steffi van Wessel
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  2. Tjalina Hamerlynck
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  3. Huib van Vliet
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  4. Steven Weyers
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  5. Benedictus Schoot
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Contributions

Steffi: protocol development, data collection, data management, statistical analysis, data interpretation, manuscript writing, manuscript editing. Tjalina, Huib, Steven, Benedictus: protocol development, data collection, data interpretation, manuscript editing.

Corresponding author

Correspondence to Steffi van Wessel.

Ethics declarations

Conflict of interest

Huib van Vliet and Benedictus Schoot report personal fees from Medtronic for lectures and consulting on hysteroscopic morcellation, outside the submitted work. Steffi van Wessel, Tjalina Hamerlynck and Steven Weyers have nothing to disclose.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Ghent University hospital (09/01/2018).

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Informed consent was obtained from all individual participants included in the study.

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van Wessel, S., Hamerlynck, T., van Vliet, H. et al. Clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr™ 5fr, for the resection of endometrial polyps in an office setting. Arch Gynecol Obstet 308, 893–900 (2023). https://doi.org/10.1007/s00404-023-06995-w

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