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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age>18

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Uterosacral suspension

    Procedure/Surgery

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

  • Hysterectomy by vNOTES approach

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Hysterectomy by vNOTES approach followed by uterosacral suspensionActive comparator 2 interventions
Group B: Hysterectomy by vNOTES approachPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal length difference (Delta)

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

Time frame
From intubating to extubating the patient during surgery

Secondary outcomes

1

Surgery length

Surgical length in minutes

Time frame
From intubating to extubating the patient during surgery
2

Surgical complications

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

Time frame
From intubating to extubating the patient during surgery
3

Visual analog scale (VAS) score

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.

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

Other outcomes

Sponsors and contacts

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