Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.
Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
PLoS One. 2023 Mar 17;18(3):e0282149. doi: 10.1371/journal.pone.0282149. eCollection 2023.
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.
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).
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.
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.
Name of the registry: ClinicalTrials.gov; Number Identifier: NCT05332132.
子宫大小是决定微创妇科手术方法可行性的重要因素之一。传统的机电式组织切碎器是一种众所周知的工具，但并非没有缺陷。我们旨在评估一种新型宫腔内电力组织切碎器用于子宫缩小的可行性和安全性，以克服在子宫切除术中的这些局限性。
这是一项单臂、观察性研究，于 2022 年 4 月至 2022 年 7 月在一家三级医疗中心进行。在 10 例子宫切除术后子宫（离体）中测试了一种新型宫腔内组织切碎器缩小子宫大小的可行性和安全性。
该试验共检查了 10 例子宫。在手术过程中未发生重大并发症。所有 10 例（10 例）子宫均成功缩小（缩小范围为 9%至 54%）。使用 Heracure 器械的平均切除时间为 4.3 分钟（范围：1 分钟至 10 分钟）。子宫平均重量减轻 21%，周长平均减少 25%。术后盐水注射后，子宫/浆膜外层未见渗漏。
在这项新的实验中，我们验证了 Heracure 器械用于经阴道宫腔内子宫切碎以缩小子宫大小的可行性和安全性。该技术可以通过阴道切口快速、轻松地切除子宫。
注册名称：ClinicalTrials.gov；注册号：NCT05332132。
