{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T13:35:13Z","timestamp":1789133713436,"version":"build-2803163510"},"reference-count":13,"publisher":"Galenos Yayinevi","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Facts Views Vis ObGyn"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:p>Background: In France, 62,000 hysterectomies are performed per year, 70% of which are benign. The choice of approach (laparotomy, laparoscopy or vaginal route) is particularly important in the case of large uterus (&gt; 280g) which are associated with a higher risk of complications. The current data are not sufficient to favour one or other approach. A new medical device, the vNOTES (Natural Vaginal Orifice Transluminal Endoscopy System), offers the advantage of both laparoscopic and vaginal route for pelvic surgery.\n\nObjectives: To demonstrate the superiority in terms of intraoperative and postoperative complications of the use of a natural orifice transluminal endoscopic hysterectomy system (vNOTES) versus laparoscopic hysterectomy for benign pathologies on estimated large volume uteri (&gt;280g)\n\nMaterials and Methods: A randomised, double-blind, superiority trial will be performed at five hospital centres. Women with benign uterine pathology requiring hysterectomy and with a large uterus (&gt; 280g) will be randomised to receive either laparoscopic or vNOTES hysterectomy.\n\nMain outcome measures: The primary outcome will be the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Secondary outcomes will be conversion during surgery, duration of surgery and hospitalisation, postoperative pain, postoperative complications, resumption of sexual life and satisfaction with the surgical team.\n\nResults: 248 women will be randomised.\n\nConclusion: This trial will provide a better understanding of the approach to large uteri optimise the care of these thousands of women undergoing hysterectomy.\n\nWhat\u2019s new? This trial will evaluate the vNotes for large uteri.<\/jats:p>","DOI":"10.52054\/fvvo.15.3.083","type":"journal-article","created":{"date-parts":[[2023,9,26]],"date-time":"2023-09-26T11:54:18Z","timestamp":1695729258000},"page":"277-281","source":"Crossref","is-referenced-by-count":5,"title":["vNOTEsHC : Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopic for large uteri: study protocol for a multicentre randomised controlled trial"],"prefix":"10.52054","volume":"15","author":[{"given":"J","family":"Druenne","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Presles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Corsini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Campagne Loiseau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Curinier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Mansour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Lamblin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Q","family":"Reboul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Chauleur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2811","published-online":{"date-parts":[[2023,9]]},"reference":[{"key":"ref0","doi-asserted-by":"publisher","unstructured":"Baekelandt JF, De Mulder PA, Le Roy I et al. Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery versus Laparoscopy as a Day-Care Procedure: A Randomised Controlled Trial. BJOG. 2019;126:105-13.","DOI":"10.1111\/1471-0528.15504"},{"key":"ref1","doi-asserted-by":"publisher","unstructured":"Baekelandt JF, De Mulder PA, Le Roy I et al. Adnexectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery versus Laparoscopy: Results of a First Randomised Controlled Trial (NOTABLE Trial). Randomised Controlled Trial. BJOG. 2021;128:1782-91.","DOI":"10.1111\/1471-0528.16838"},{"key":"ref2","doi-asserted-by":"publisher","unstructured":"Baekelandt J. Transvaginal Natural-Orifice Transluminal Endoscopic Surgery: A New Approach to Myomectomy. Fertil Steril. 2018a;109:179.","DOI":"10.1016\/j.fertnstert.2017.09.009"},{"key":"ref3","doi-asserted-by":"publisher","unstructured":"Baekelandt J. Transvaginal Natural Orifice Transluminal Endoscopic Surgery: A New Approach to Ovarian Cystectomy. Fertil Steril. 2018b;109:366.","DOI":"10.1016\/j.fertnstert.2017.10.037"},{"key":"ref4","doi-asserted-by":"publisher","unstructured":"Baekelandt JF, De Mulder PA, Le Roy I et al. Transvaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) Adnexectomy for Benign Pathology Compared with Laparoscopic Excision (NOTABLE): A Protocol for a Randomised Controlled Trial. BMJ Open. 2018c;8:e018059.","DOI":"10.1136\/bmjopen-2017-018059"},{"key":"ref5","doi-asserted-by":"publisher","unstructured":"Baekelandt JF. New Retroperitoneal Transvaginal Natural Orifice Transluminal Endoscopic Surgery Approach to Sentinel Node for Endometrial Cancer: A Demonstration Video. J Minim Invasive Gynecol. 2019;26:1231-2.","DOI":"10.1016\/j.jmig.2019.05.002"},{"key":"ref6","doi-asserted-by":"publisher","unstructured":"Dara\u00ef E, Soriano D, Kimata P et al. Vaginal Hysterectomy for Enlarged Uteri, with or without Laparoscopic Assistance: Randomised Study. Obstet Gynecol. 2001;97:712-6.","DOI":"10.1097\/00006250-200105000-00013"},{"key":"ref7","doi-asserted-by":"publisher","unstructured":"Deffieux X, de Rochambeau B, Ch\u00eane G et al. Hyst\u00e9rectomie pour pathologie b\u00e9nigne : recommandations pour la pratique clinique. J Gynecol Obstet Biol Reprod (Paris). 2015;44:1219-27.","DOI":"10.1016\/j.jgyn.2015.09.027"},{"key":"ref8","doi-asserted-by":"publisher","unstructured":"Gendy R, Walsh CA, Walsh SR et al.Vaginal Hysterectomy versus Total Laparoscopic Hysterectomy for Benign Disease: A Metaanalysis of Randomised Controlled Trials. Am J Obstet and Gynecol. 2011;204:388.e1-8.","DOI":"10.1016\/j.ajog.2010.12.059"},{"key":"ref9","doi-asserted-by":"publisher","unstructured":"Hwang JL, Seow KM, Tsai YL et al. Comparative Study of Vaginal, Laparoscopically Assisted Vaginal and Abdominal Hysterectomies for Uterine Myoma Larger than 6 Cm in Diameter or Uterus Weighing at Least 450 g: A Prospective Randomised Study. Acta Obstet Gynecol Scand. 2002;81:1132-8.","DOI":"10.1034\/j.1600-0412.2002.811206.x"},{"key":"ref10","doi-asserted-by":"publisher","unstructured":"Lee SH, Oh SR, Cho YJ et al. Comparison of Vaginal Hysterectomy and Laparoscopic Hysterectomy: A Systematic Review and Meta-Analysis. BMC Womens Health. 2019;19:83.","DOI":"10.1186\/s12905-019-0784-4"},{"key":"ref11","doi-asserted-by":"publisher","unstructured":"Lowenstein L, Matanes E, Lauterbach R et al. Transvaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES) for Omentectomy \u2013 A Case Series. Surg Oncol. 2020;34:186-9.","DOI":"10.1016\/j.suronc.2020.04.018"},{"key":"ref12","doi-asserted-by":"publisher","unstructured":"Nulens K, Bosteels J, De Rop C et al. VNOTES Hysterectomy for Large Uteri: A Retrospective Cohort Study of 114 Patients. J Minim Invasive Gynecol. 2021;28:1351-6.","DOI":"10.1016\/j.jmig.2020.10.003"}],"container-title":["Facts, Views and Vision in ObGyn"],"original-title":[],"language":"en","deposited":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T05:55:54Z","timestamp":1739512554000},"score":1,"resource":{"primary":{"URL":"https:\/\/fvvo.eu\/articles\/doi\/FVVO.15.3.083\">10.52054"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9]]},"references-count":13,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,9,24]]},"published-print":{"date-parts":[[2023,9]]}},"URL":"https:\/\/doi.org\/10.52054\/fvvo.15.3.083","relation":{},"ISSN":["2684-4230","2032-0418"],"issn-type":[{"value":"2684-4230","type":"electronic"},{"value":"2032-0418","type":"print"}],"subject":[],"published":{"date-parts":[[2023,9]]}}}