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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07413861
Status
Not Yet Recruiting

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Conditions

  • Hysterectomy
  • Prolapse Pelvic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Hysterectomy by vNOTES approach followed by uterosacral suspension
    Two suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy
  • Placebo Comparator: Hysterectomy by vNOTES approach
    No additional intervention will be done following hysterectomy

Primary Outcome Measure

Vaginal length difference (Delta) [ Time Frame: From intubating to extubating the patient during surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of TexasHoustonTexas77030-

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By research site
University of Texas· Houston, TX

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