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

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 non-prolapsed 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.

Ten patients were screened for eligibility, and all were found eligible. Ten uteri were examined in this trial. No major complications occurred during the procedure. During the study period, various uteri sizes were selected. Mean pre-procedure uterus size was 290 gr. (weight range: 40–793 gr.; 12–36 cm/ circumference). All ten (10) uteri were successfully reduced in size, (mean uterus weight reduction was 21% with mean circumference reduction of 25% (reduction range: 9% - 54%)). The mean resection time using Heracure device was 4.3 minutes (range: 1– 10min). Table 1 presents an overview of the patient demographic and surgical data. BMI: body mass index. No leakage was observed from the outer surface of the uterus/serosa at the saline injection post-procedure examination. All uteri were benign upon pathological examination. Patient list and peri-operative data are presented in Table 2 . BMI: body mass index, W: weeks, VH: Vaginal hysterectomy, LH: Laparoscopic hysterectomy, LAVH: Laparoscopic assisted vaginal hysterectomy, TAH: Total abdominal hysterectomy, PMB: Post-menopausal bleeding. *Lynch syndrome.

In conclusion, the Heracure device is a novel tool for the reduction of the uterine size and may potentially be applied to perform vaginal/ laparoscopic hysterectomy in specific cases of larger volume size uteri, which require size reduction prior to removal. We hope this novel device will enable more gynecologic surgeons to perform hysterectomies in an easier and more rapid manner, yet with assured safety in cases of limited access, due to large uterine size or limited laparoscopic approach. Future in-vivo trials are warranted to strengthen the findings of this limited observational cohort for the safety and efficacy of the procedure.

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 the post-hysterectomy uterus. The primary outcome evaluated was the procedure’s safety. The main adverse effect was defined as uterine perforation at the end of procedure, which was assessed by inflating the uterus with saline. Secondary outcomes were the device’s success, which was defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure. The study was approved by the Meir Medical Center Ethics Committee in July 2021; approval number MMC- 0335–20 and in the ClinicalTrials.gov (Identifier: NCT05332132 ). Each patient signed and dated a written informed consent form (ICF) prior to the procedure. The authors confirm that all ongoing and related trials for this intervention are registered. Study protocol is attached separately. This study used the implementation of enhancing the Quality and Transparency of health Research (EQUATOR) network guidelines. The author performed 10 hysterectomies and performed morcellation on their uterus post-surgery, to evaluate the feasibility of this novel technique (Ex-vivo experiment). Flow diagram of the study is shown in Fig 1 . Patients were selected based on the following inclusion criteria: undergoing hysterectomy (vaginal, laparoscopic, abdominal) due to benign gynecologic disease; Exclusion criteria: suspicion for malignancy (on ultrasound, prior endometrial biopsy, MRI). (CONSORT 2010 flow diagram). The following patient and peri-procedure data were collected and retrospectively analyzed: Uterus size and volume, the duration of morcellation for uterine size reduction and perforation rate. The duration of the morcellation was defined as the time from the placement of the morcellator to the end of the procedure (reduction of uterus size). Uterus perforation by the Heracure device was an intra-procedure complication. The Heracure System consists of the following components: Heracure Resection Device ( Fig 2 ) Off the shelf FDA cleared motor control unit and foot pedal Off the shelf FDA cleared external vacuum source device with sterile tubing sets (Fig 2, Republished from Heracure CP-0300 under a CC BY license, with permission from Heracure company, original copyright 2023). The Control Unit contains FDA cleared electric motor and firmware motor controller that drives the Heracure Resection Device. The Control Unit is activated and deactivated by a foot pedal. The resection device features a rotating/oscillating side window cutter. The resected tissue particles and the irrigation fluid are transported using a vacuum source to a distal tissue collection container. The study was conducted on 10 extirpated uteri after the end of each hysterectomy (Ex-vivo). The weight and size of each extirpated uterus was recorded prior to procedure. Prior to Heracure device deployment, the cervix was dilated using Hagar dilators of max 13mm. The Heracure resection device was inserted into the uterine cavity through the cervix (Figs 3 and 4 ). During the morcellation procedure, a protective barrier was wrapped around the uterus and was used for the isolation and prevention of a potential intraperitoneal visceral injury ( Fig 5A and 5B ). In the future, during the in-vivo procedure, a proximity magnetic sensor located inside the protective barrier, will automatically stop the morcellation motor, when the morcellator knives are close to the barrier, to prevent any iatrogenic damage. A laparoscopic camera will accompany the procedure to verify safety and prevent potential visceral injury. (Fig 3, Republished from Heracure CP-0300 under a CC BY license, with permission from Heracure company, original copyright 2023). (Fig 4, Republished from Heracure CP-0300 under a CC BY license, with permission from Heracure company, original copyright 2023). (Fig 5A and 5B, Republished from Heracure CP-0300 under a CC BY license, with permission from Heracure company, original copyright 2023). The morcellation procedures were performed by the surgical gynecologist (principal investigator), and the resection time was recorded. Upon completion of the resection procedure, the reduced weight and size of extirpated uterus was recorded. Post-procedure included testing the uterus for leakage: in case of intact fallopian tubes, the tubes were sealed, and uterine cavity was fully filled with saline using a syringe and the outer surface of the uterus was visually observed for leakage ( Fig 6 ). Following the completion of the leakage testing, the extirpated uterus and resected tissue (debris) were collected and sent for routine pathology. (Fig 6, Republished from Heracure CP-0300 under a CC BY license, with permission from Heracure company, original copyright 2023). Nominal data were described as numbers and percentages. Continuous data were assessed for normal distribution (Shapiro-Wilk test) and were described as mean ± SD or median (minimum-maximum). All analyses were performed using SPSS-26 software (IBM, Armonk, NY, USA).

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