The Sealing Effect of the Magnetic-Sealing Uterine Manipulator in Patients with Early-Stage Cervical Cancer

Background: The traditional uterine manipulator is considered the main reason for the shorter survival of patients who undergo minimally invasive surgery (MIS) for the treatment of early-stage cervical cancer. The aim of this study was to assess the sealing effect of a Magnetic-Sealing Uterine Manipulator (MUM) in the isolated uterus. Methods: The study was performed on patients with early-stage cervical cancer who underwent radical laparotomy hysterectomy from November 2019 to January 2020 . We used right-angle forceps closure tests (group 1 and 3) as the control test. The MUM closure test (group 2) and the control test were carried out in an isolated uterus. DNA ploidy analysis system was used to analyze the exfoliated cells. Statistical analysis was performed using Mann-Whitney U test to assess the sealing effect of MUM. Findings: We identified eight patients. All of their tumors were less than 4.0 cm and had none regional nodal metastasis. The mean numbers of exfoliated tumor cells in groups 1, 2, and 3 were 58, 9, and 103, respectively. The number of exfoliated tumor cells was significantly lower in group 2 compared with group 3 (p=0·028). And we observed no significant difference between group 1 and group 2 (p=0·130). Furthermore, there was no significant difference between group 1 and group 3 (p=0·721). Interpretation: The sealing effect for MUM was the same as, or even better than, that for the right-angle forceps. The MUM can effectively seal the cervical cancer cells in the cup cover and avoid the dissemination of tumor cells during MIS. Funding Statement: This work was supported by the Clinical Research Award of the First Affiliated Hospital of Xi’an Jiaotong University, China (XJTU1AF-2018-017, XJTU1AF-CRF-2019-002), the Major Basic Research Project of Natural Science of Shaanxi Provincial Science and Technology Department (2018JM7073, 2017ZDJC-11), the Key Research and Development Project of Shaanxi Provincial Science and Technology Department (2017ZDXM-SF-068, 2019QYPY-138), the Shaanxi Provincial Collaborative Technology Innovation Project (2017XT-026, 2018XT-002), and the Medical Research Project of Xi’an Social Development Guidance Plan (2017117SF/YX011-3). Declaration of Interests: The authors declare no potential conflicts of interest. Ethics Approval Statement: The study was approved by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (2019-W17). All patients were fully informed of the purpose and study design and provided written consent before their participation.