An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study

PLOS ONE RESEARCH ARTICLE An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study Meir Pomeranz1,2, Ron Schonman1,2, Yael Yagur1,2, Rina Tamir Yaniv1,2, Zvi Klein1,2, Yair Daykan ID1,2,3* a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel, 2 Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel, 3 Department of Urogynaecology, Cork University Maternity Hospital, Cork, Ireland * Abstract Objective OPEN ACCESS Citation: Pomeranz M, Schonman R, Yagur Y, Tamir Yaniv R, Klein Z, Daykan Y (2023) An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study. PLoS ONE 18(3): e0282149. https://doi.org/ 10.1371/journal.pone.0282149 Editor: Andrea Giannini, Sapienza University of Rome: Universita degli Studi di Roma La Sapienza, ITALY Received: October 11, 2022 Uterine size is one of the essential factors determining the feasibility of a minimally invasive gynecologic surgery approach. A traditional electromechanical morcellator is a well-known tool but not without flaws. We aim to assess feasibility and safety of a novel intrauterine power morcellation device for uterine size reduction to overcome these limitations during hysterectomy. Methods This single-arm, observational study was conducted in a single tertiary care medical center from April 2022 to July 2022. Feasibility and safety of a novel intrauterine morcellation device for uterine size reduction was tested in ten post-hysterectomy uteri (Ex-vivo). Measurements and main results Accepted: January 30, 2023 Published: March 17, 2023 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0282149 Copyright: © 2023 Pomeranz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Ten uteri were examined in this trial. No major complications occurred during the procedure. All ten (10) uteri were successfully reduced in size (size reduction range was between 9% to 54%). The average resection time using the Heracure Device was 4.3 minutes (range: 1min– 10min). Mean uterus weight reduction was 21%, with a mean circumference reduction of 25%. No leakage was observed from the outer surface of the uterus/serosa after the saline injection post-procedure examination. Conclusion In this novel experiment, we verified the feasibility and safety of the Heracure device for vaginal intra-uterine morcellation for uterine size reduction. This technique could enable rapid and easy removal of the uterus through the vaginal orifice. Clinical trial registration Name of the registry: ClinicalTrials.gov; Number Identifier: NCT05332132. PLOS ONE | https://doi.org/10.1371/journal.pone.0282149 March 17, 2023 1 / 14 PLOS ONE Funding: Yes The institute (hospital) received payment fees/devices from Heracure Medical Ltd. to support patient participation in the study https:// www.linkedin.com/company/heracure-medical-ltd The authors did not receive personal payment. The founder has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: The authors have declared that no competing interests exist. Heracure device for vaginal intra-uterine morcellation is efficient and safe Introduction Minimally invasive gynecologic surgery is a major surgical technique that offers advantages over laparotomy, such as minimized use of narcotics, less intraoperative blood loss, shorter operative time, and rapid recovery [1–4]. Vaginal hysterectomy is the preferred approach for most patients [5]. Uterine size is one of the main parameters in determining the hysterectomy surgical approach: a uterine measurement of ~� 16 weeks and some degree of prolapse allows, in most cases, for a vaginal approach [6]. Laparoscopic approach is employed for cases of nonprolapsed uterus and cases with uterine measurement of less than 18–20 weeks [1, 5]. In some cases of enlarged uterine mass, morcellation is needed [7–9] and performed with the help of the in-bag (contained) morcellation [10]. For ~100 years manual morcellation was performed using a scalpel; while modern morcellation uses electromechanical morcellators that rapidly remove specimens, through the small laparoscopic incision, thus benefiting from the advantages of minimally invasive gynecologic surgery [11]. However, use of power morcellation in the peritoneal cavity was found to increase the risk of both benign and malignant cell dispersion [12, 13]. In 2020 the USA’s Food and Drug Administration (FDA) released a safety update warning [14] limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy; when morcellation is appropriate, only contained morcellation should be performed. This warning aims to reduce the risk of disseminating malignant tissue in the treatment of benign-looking uterine fibroids. The immediate effect was a decline in the overall rate of minimally invasive surgery for these indications, as well as a sharp decline in the use of intraperitoneal morcellation [15, 16]. To maintain use of minimally invasive laparoscopic procedures solutions for in-bag power morcellation have evolved, beyond the use of scalpel morcellation [14]. Nonetheless, some limitations inherent to the use of in-bag power morcellation were shown in previous studies: this technique is cumbersome, time-consuming, with risk of perforation of the bag [17–19]. Therefore, we were eager to find a solution for the power morcellation technique suitable for minimally invasive laparoscopic or vaginal surgeries that will provide the patient with the best surgical technique, with the lowest risk rate and will maximize her recovery rate. The aim of this study was to evaluate the safety and feasibility of the intra-uterine morcellation device for uterine size reduction, to overcome these limitations during laparoscopic/vaginal hysterectomy. Materials and methods This observational study was conducted in a single tertiary care medical center from April 18, 2022, to July 31, 2022. Participants were recruited from a list of patients consented for hysterectomy. Feasibility assessment of the morcellation device was employed on the post hysterectomy uterus (Ex-vivo) to reduce the uterine size. No intervention was applied in the patients, as the study only investigated (...truncated)