Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension

Обзор

As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health. One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery. OBJECTIVE AND HYPOTHESIS: This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.

Подробное описание

1. BACKGROUND AND RATIONALE:

Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimally invasive surgical technique that combines the advantages of laparoscopy with a natural orifice approach, eliminating the need for abdominal incisions. By accessing the peritoneal cavity via the vagina, vNOTES offers benefits such as reduced postoperative pain, faster recovery, fewer wound-related complications, and improved cosmetic outcomes. Over the past decade, it has been successfully applied to a broad spectrum of gynecologic procedures, including adnexal surgery and hysterectomy, with growing evidence supporting its safety and feasibility in both benign and complex cases. As the adoption of vNOTES expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health.

One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. In traditional vaginal or abdominal hysterectomy, preserving or reconstructing apical support is considered standard of care to minimize this risk.

Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Multiple randomized and observational studies have demonstrated that performing USLS prophylactically can significantly reduce the incidence of postoperative vault prolapse, aligning with pelvic reconstructive principles and the American College of Obstetricians and Gynecologists (ACOG) recommendations. Beyond prevention, USLS also improves pelvic floor function, reduces the need for future surgery, and preserves vaginal axis and length. Its application in minimally invasive hysterectomy is now routine in many centers, yet in vNOTES procedures, this important step has not been widely integrated.

Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery. 2. OBJECTIVE AND HYPOTHESIS:

This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.

Вмешательства

• Процедура Uterosacral suspension
  Placement of two suspension sutures on the uterosacral ligament on each side
• Процедура Hysterectomy by vNOTES approach
  Hysterectomy with or without adnexectomy performed by vaginal natural orifice transluminal endoscopic surgery (vNOTES)

Первичные конечные точки

• Vaginal length difference (Delta) [Срок оценки: From intubating to extubating the patient during surgery]

Вторичные конечные точки (3)

• Surgery length [Срок оценки: From intubating to extubating the patient during surgery]
• Surgical complications [Срок оценки: From intubating to extubating the patient during surgery]
• Visual analog scale (VAS) score [Срок оценки: From immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)]

Критерии участия

Критерии включения

• Age>18
• All women undergoing vNOTES hysterectomy ± Bilateral salpingectomy/salpingo-oopherectomy for benign gynecological indication

Критерии исключения

• Exclusion for vNOTES surgery: pelvic inflammatory disease, previous rectal surgery, suspected malignancy, radiation
• Indication for surgery: elvic prolapse
• Other surgical interventions planned for the procedure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Texas — Houston

Публикации

• Martins SB, Castro RA, Takano CC, Marquini GV, Oliveira LM, Martins Junior PCF, Dias MM, Girao MJBC, Sartori MGF. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial. Rev Bras Ginecol Obstet. 2023 Oct;45(10):e584-e593. doi: 10.1055/s-0043-1772592. Epub 2023 Nov 9. PMID 37944925
• Manodoro S, Frigerio M, Milani R, Spelzini F. Tips and tricks for uterosacral ligament suspension: how to avoid ureteral injury. Int Urogynecol J. 2018 Jan;29(1):161-163. doi: 10.1007/s00192-017-3497-y. Epub 2017 Oct 16. PMID 29038833
• Aronson MP, Aronson PK, Howard AE, Morse AN, Baker SP, Young SB. Low risk of ureteral obstruction with "deep" (dorsal/posterior) uterosacral ligament suture placement for transvaginal apical suspension. Am J Obstet Gynecol. 2005 May;192(5):1530-6. doi: 10.1016/j.ajog.2004.10.608. PMID 15902153
• Altman D, Falconer C, Cnattingius S, Granath F. Pelvic organ prolapse surgery following hysterectomy on benign indications. Am J Obstet Gynecol. 2008 May;198(5):572.e1-6. doi: 10.1016/j.ajog.2008.01.012. Epub 2008 Mar 20. PMID 18355787
• Lerner VT, May G, Iglesia CB. Vaginal Natural Orifice Transluminal Endoscopic Surgery Revolution: The Next Frontier in Gynecologic Minimally Invasive Surgery. JSLS. 2023 Jan-Mar;27(1):e2022.00082. doi: 10.4293/JSLS.2022.00082. PMID 36818766
• Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20. PMID 31444108
• Housmans S, Noori N, Kapurubandara S, Bosteels JJA, Cattani L, Alkatout I, Deprest J, Baekelandt J. Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications. J Clin Med. 2020 Dec 7;9(12):3959. doi: 10.3390/jcm9123959. PMID 33297354

Идентификаторы

NCT: NCT07413861 · HSC-MS-25-0000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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