NCT07379411 Are There Benefits of Using Energy-based Devices for Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy Compared to a Standard Cold Approach?
| NCT ID | NCT07379411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wolfson Medical Center |
| Condition | Pelvic Organ Prolapse (POP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-10-16 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares two methods for removing the fallopian tubes and ovaries during vaginal hysterectomy for pelvic organ prolapse. One method uses an energy-based surgical device called LigaSure Maryland, which seals blood vessels using electrical energy. The other method is the standard surgical approach, which involves clamping, cutting, and suturing the tissue. The purpose of the study is to determine whether the use of the LigaSure device is as safe as, or more effective than, the standard technique, in terms of procedure duration, blood loss, postoperative pain, length of hospital stay, and complication rates. Women who are scheduled to undergo vaginal hysterectomy for pelvic organ prolapse and for whom removal of the fallopian tubes and ovaries is recommended may participate in the study. Participants will be randomly assigned to one of two groups, receiving either the LigaSure technique or the standard surgical technique. The decision to perform removal of the fallopian tubes and ovaries will be made before surgery based on standard medical indications. Participants will not be informed which surgical technique is used during their operation. Surgical outcomes between the two groups will be compared to evaluate safety and effectiveness.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07379411 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Organ Prolapse (POP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07379411 currently recruiting?
Yes, NCT07379411 is actively recruiting participants. Contact the research team at mckerko@gmail.com for enrollment information.
Where is the NCT07379411 trial being conducted?
This trial is being conducted at Holon, Israel.
Who is sponsoring the NCT07379411 clinical trial?
NCT07379411 is sponsored by Wolfson Medical Center. The trial plans to enroll 70 participants.