Are There Benefits of Using Energy-based Devices for Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy Compared to a Standard Cold Approach?
Trial Parameters
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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.