Removing fallopian tubes and ovaries during vaginal hysterectomy: energy-sealing device versus standard technique
Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wolfson Medical Center Government |
| Locations | 1 site (Holon) |
| Trial ID | NCT07379411 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Holon
- Wolfson Medical Center — Holon, Israel (Recruiting)
Study contacts
- Study coordinator: Michael Babin, MD
- Email: mckerko@gmail.com
- Phone: 972538535549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.