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NCT Number: NCT07413861

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas

Houston, Texas, 77030, United States

About this study

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Vaginal length difference (Delta)

    Time frame: From intubating to extubating the patient during surgery

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

Secondary outcomes

  1. Surgery length

    Time frame: From intubating to extubating the patient during surgery

    Surgical length in minutes

  2. Surgical complications

    Time frame: From intubating to extubating the patient during surgery

    Evaluated as a compound parameter including: Excessive bleeding (>500 cc), damage to adjacent organ (bladder, bowel, great vessel), change in surgical approach

  3. Visual analog scale (VAS) score

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Mohr Sasson, MD

CONTACT

[email protected]

346-270-4682

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: VENUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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