Recruiting

Uterosacral Suspension

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07413861

Conditions

Prolapse Pelvic

Hysterectomy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Uterosacral suspension

Hysterectomy by vNOTES approach

Study Details

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.

Conditions

Prolapse Pelvic

Hysterectomy

Study ID

NCT07413861

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Uterosacral suspension

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

Hysterectomy by vNOTES approach

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Texas

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.