42
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objective

          This prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer.

          Methods

          In this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up.

          Results

          In the study, 154 patients (76 in arm A and 78 in arm B) were finally included. No significant differences were recorded regarding the baseline characteristics. A statistically significant difference was found in operative time for the laparoscopic staging (p=0.005), while no differences were reported for the robotic procedures (p=0.419). The estimated blood loss was significantly lower in arm A (p=0.030). No statistically significant differences were recorded between the two study groups in terms of peritoneal cytology, LVSI (p=0.501), and pattern of LVSI (p=0.790). No differences were detected in terms of overall survival and disease-free survival (p=0.996 and p=0.480, respectively). Similarly, no differences were recorded in the number of recurrences, 6 (7.9%) in arm A and 4 (5.2%) in arm B (p=0.486). The use of the uterine manipulator had no impact on DFS both at univariable and multivariable analyses.

          Conclusions

          The intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging.

          Clinical Trial Registration

          https://clinicaltrials.gov, identifier (NCT: 02762214)

          Related collections

          Most cited references46

          • Record: found
          • Abstract: found
          • Article: not found

          A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study.

          Sentinel-lymph-node mapping has been advocated as an alternative staging technique for endometrial cancer. The aim of this study was to measure the sensitivity and negative predictive value of sentinel-lymph-node mapping compared with the gold standard of complete lymphadenectomy in detecting metastatic disease for endometrial cancer.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Surgical approach to hysterectomy for benign gynaecological disease.

            The four approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic-assisted hysterectomy (RH).
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Classification of radical hysterectomy.

              Since the first publications about surgery for cervical cancer, many radical procedures that accord with different degrees of radicality have been described and done. Here, we propose a basis for a new and simple classification for cervical-cancer surgery, taking into account the curative effect of surgery and adverse effects, such as bladder dysfunction. The international anatomical nomenclature is used where it applies. For simplification, the classification is based only on lateral extent of resection. We describe four types of radical hysterectomy (A-D), adding when necessary a few subtypes that consider nerve preservation and paracervical lymphadenectomy. Lymph-node dissection is considered separately: four levels (1-4) are defined according to corresponding arterial anatomy and radicality of the procedure. The classification applies to fertility-sparing surgery, and can be adapted to open, vaginal, laparoscopic, or robotic surgery. In the future, internationally standardised description of techniques for communication, comparison, clinical research, and quality control will be a basic part of every surgical procedure.
                Bookmark

                Author and article information

                Contributors
                Journal
                Front Oncol
                Front Oncol
                Front. Oncol.
                Frontiers in Oncology
                Frontiers Media S.A.
                2234-943X
                10 September 2021
                2021
                : 11
                : 720894
                Affiliations
                [1] 1Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                [2] 2Institute of Obstetrics and Gynecology, Universita’ Cattolica del Sacro Cuore , Rome, Italy
                [3] 3Department of Human Pathology of Adult and Childhood “G. Barresi,” Unit of Gynecology and Obstetrics, University of Messina , Messina, Italy
                [4] 4STAR Center (Statistics Technology Archiving Research), Fondazione Policlinico Universitario Agostino Gemelli-IRCCS , Rome, Italy
                [5] 5Department of Gynecologic Oncology, ARNAS Civico Di Cristina Benfratelli, Università di Palermo , Palermo, Italy
                [6] 6Department of Obstetrics and Gynecology, AOUI Verona, Università di Verona , Verona, Italy
                [7] 7Division of Obstetrics and Gynecology, Università degli studi di Messina, Policlinico G. Martino , Messina, Italy
                [8] 8Division of Gynecologic Oncology, Gemelli-Molise, Università Cattolica del Sacro Cuore , Campobasso, Italy
                [9] 9Department of Maternal and Child Health, University-Hospital of Udine , Udine, Italy
                [10] 10Department of Gynecology and Obstetrics of Parma, University of Parma , Parma, Italy
                Author notes

                Edited by: Giovanni Battista Levi Sandri, San Camillo-Forlanini Hospital, Italy

                Reviewed by: Jvan Casarin, University of Insubria, Italy; Matteo Morotti, Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland

                *Correspondence: Francesco Cosentino, francesco.cosentino@ 123456gemellimolise.it

                This article was submitted to Surgical Oncology, a section of the journal Frontiers in Oncology

                Article
                10.3389/fonc.2021.720894
                8461311
                34568050
                5cea3ff4-269f-4633-b70b-24132b7bafb6
                Copyright © 2021 Gueli Alletti, Perrone, Fedele, Cianci, Pasciuto, Chiantera, Uccella, Ercoli, Vizzielli, Fagotti, Gallotta, Cosentino, Costantini, Restaino, Monterossi, Rosati, Turco, Capozzi, Fanfani and Scambia

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 05 June 2021
                : 09 August 2021
                Page count
                Figures: 2, Tables: 5, Equations: 0, References: 46, Pages: 10, Words: 5468
                Categories
                Oncology
                Original Research

                Oncology & Radiotherapy
                hysterectomy,endometrial cancer,robotic hysterectomy,laparoscopic hysterectomy,minimally invasive hysterectomy,uterine manipulator

                Comments

                Comment on this article

                scite_
                0
                0
                0
                0
                Smart Citations
                0
                0
                0
                0
                Citing PublicationsSupportingMentioningContrasting
                View Citations

                See how this article has been cited at scite.ai

                scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.

                Similar content110

                Cited by6

                Most referenced authors464