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NCT07413861 · The University of Texas Health Science Center, Houston

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

(VENUS)

What this study is about

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.

View original scientific description

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.

Interventions

PROCEDURE

Uterosacral suspension

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

PROCEDURE

Hysterectomy by vNOTES approach

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

Primary outcome measures

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

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

Exclusion criteria

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

Where

  • Houston, Texas

Related conditions & keywords

Prolapse PelvicHysterectomypreventionpelvic prolapseuterosacral suspensionvaginal surgeryvaginal natural orifice transluminal surgery

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations

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1 of 50 participants interested
2% interest

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RECRUITING

Houston

Texas

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Prolapse Pelvic Treatment Options in Houston, Texas

If you're searching for Prolapse Pelvic treatment in Houston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Houston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Prolapse Pelvic. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Texas
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Prolapse Pelvic?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Prolapse Pelvic

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Prolapse Pelvic Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07413861. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.