Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07413861
Acronym
VENUS
Enrollment
50
Registered
2026-02-17
Start date
2026-03-01
Completion date
2027-12-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy, Prolapse Pelvic

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREUterosacral suspension

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

PROCEDUREHysterectomy by vNOTES approach

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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Vaginal length difference (Delta)From intubating to extubating the patient during surgeryThe calculated difference in total vaginal length before minus after surgery, evaluated by hysterometer

Secondary

MeasureTime frameDescription
Surgery lengthFrom intubating to extubating the patient during surgerySurgical length in minutes
Surgical complicationsFrom intubating to extubating the patient during surgeryEvaluated as a compound parameter including: Excessive bleeding (\>500 cc), damage to adjacent organ (bladder, bowel, great vessel), change in surgical approach
Visual analog scale (VAS) scoreFrom immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)Pain will be assessed using a visual analog scale (VAS) ranging from 1 to 10, where 1 represents no pain and 10 represents the worst imaginable pain.

Countries

United States

Contacts

CONTACTAya Mohr Sasson, MD
aya.mohrsasson@uth.tmc.edu346-270-4682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026