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Are There Benefits of Using Energy-based Devices for Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy Compared to a Standard Cold Approach?
Sponsor: Wolfson Medical Center
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.
Official title: Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-10-16
Completion Date
2027-09
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
LigaSure MaryLand
Energy-based vessel sealing device used to perform salpingo-oophorectomy.
Standard salpingo-oophorectomy technique
Salpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices.
Locations (1)
Wolfson Medical Center
Holon, Israel