Removing fallopian tubes and ovaries during vaginal hysterectomy: energy-sealing device versus standard technique
Official title: Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study
Run by Wolfson Medical Center · NCT07379411 · Data updated 2026-11-12
This trial tests whether using a LigaSure energy-sealing device to remove the fallopian tubes and ovaries during vaginal hysterectomy is safer, faster, or causes less blood loss and pain than the standard clamping, cutting, and suturing method for women with pelvic organ prolapse.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | Wolfson Medical Center Government |
| Locations | 1 site (Holon) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT07379411 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older scheduled for vaginal hysterectomy for pelvic organ prolapse who are recommended to undergo salpingo‑oophorectomy and can give informed consent are ideal candidates.
✕Probably not a fit
Patients with suspected or known pelvic malignancy, those planning a non‑vaginal or vNOTES approach, or those whose anatomy requires a different technique are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized controlled trial at a single center compares the LigaSure Maryland energy-based vessel-sealing device with the conventional clamp‑cut‑suture technique for opportunistic salpingo‑oophorectomy during vaginal hysterectomy for pelvic organ prolapse. Eligible women who are recommended to have salpingo‑oophorectomy at the time of their vaginal hysterectomy are randomly assigned to one of the two surgical approaches. The trial measures procedure duration, intraoperative blood loss, postoperative pain, length of hospital stay, and complication rates, with intraoperative deviations noted as exclusions. Patients with suspected pelvic malignancy or those planned for non‑vaginal approaches such as vNOTES are excluded.
Why it matters
Potential benefit: If successful, the LigaSure approach could shorten operating time, reduce blood loss and postoperative pain, and shorten hospital stay compared with the traditional technique.
How similar studies have gone: Energy-based vessel-sealing devices have demonstrated reduced operative time and blood loss in other gynecologic procedures, but randomized data specifically for opportunistic salpingo‑oophorectomy during vaginal hysterectomy are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 years or older. * Scheduled to undergo vaginal hysterectomy for pelvic organ prolapse. * Recommended to undergo opportunistic salpingo-oophorectomy according to standard clinical indications. * Able and willing to provide written informed consent. Exclusion Criteria: * Suspected or known pelvic malignancy. * Lack of informed consent. * Planned opportunistic salpingo-oophorectomy using a non-vaginal surgical approach. * Planned opportunistic salpingo-oophorectomy using a vNOTES (vaginal natural orifice transluminal endoscopic surgery) approach. * Intraoperative need to deviate from the assigned surgical technique due to anatomical or technical considerations.
Where it's running
-
Wolfson Medical Center
Holon, Israel Recruiting
Study contacts
- Study coordinator: Michael Babin, MD
- Email: mckerko@gmail.com
- Phone: 972538535549
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Risk predictor for new urinary incontinence after prolapse surgery
This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.
-
Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse
This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.
-
Poly-L-lactic acid injections for vulvovaginal tissue regeneration
This trial will try injections of poly-L-lactic acid (PLLA) versus placebo to see if they strengthen vaginal tissue and reduce bulge symptoms and sexual problems in women with stage II anterior vaginal wall prolapse (cystocele).
-
Pelvic floor mesh used in laparoscopic sacrocolpopexy to repair pelvic organ prolapse
This study tests the ProGYNious mesh to see if it safely and effectively repairs pelvic organ prolapse in adults undergoing laparoscopic surgery.
-
Paracervical block for pain control after vNOTES uterosacral ligament suspension
This will test whether a paracervical injection of bupivacaine reduces early postoperative pain in women having vNOTES uterosacral ligament suspension for pelvic organ prolapse.
-
Postpartum pelvic floor recovery and early rehabilitation after vaginal birth
This project tests whether early, individualized pelvic floor muscle training starting 2–3 weeks after a vaginal birth helps people with postpartum pelvic floor symptoms recover better than usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.