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

NCT07413861 | Not Yet Recruiting

• 1 other identifier: HSC-MS-25-0000
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolapse Pelvic; Hysterectomy

Keywords

hysterectomy; prevention; pelvic prolapse; uterosacral suspension; vaginal surgery; vaginal natural orifice transluminal surgery

Outcome Measures

Primary Outcomes (1)

• Vaginal length difference (Delta)

  The calculated difference in total vaginal length before minus after surgery, evaluated by hysterometer

  From intubating to extubating the patient during surgery

Secondary Outcomes (3)

• Surgery length

  From intubating to extubating the patient during surgery

• Surgical complications

  From intubating to extubating the patient during surgery

• Visual analog scale (VAS) score

  From immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)

Study Arms (2)

Hysterectomy by vNOTES approach followed by uterosacral suspension

ACTIVE COMPARATOR

Two suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy

Procedure: Uterosacral suspension; Procedure: Hysterectomy by vNOTES approach

Hysterectomy by vNOTES approach

PLACEBO COMPARATOR

No additional intervention will be done following hysterectomy

Procedure: Hysterectomy by vNOTES approach

Interventions

Uterosacral suspension PROCEDURE

Placement of two suspension sutures on the uterosacral ligament on each side

Hysterectomy by vNOTES approach followed by uterosacral suspension

Hysterectomy by vNOTES approach PROCEDURE

Hysterectomy with or without adnexectomy performed by vaginal natural orifice transluminal endoscopic surgery (vNOTES)

Hysterectomy by vNOTES approach; Hysterectomy by vNOTES approach followed by uterosacral suspension

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with uterus before hysterectomy planned to be performed by vNOTES surgery for benign indication
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Indication for surgery: elvic prolapse
• Other surgical interventions planned for the procedure

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Central Study Contacts

Aya Mohr Sasson, MD

CONTACT

346-270-4682; aya.mohrsasson@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)