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.
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.
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.
Parallel
LigaSure MaryLand
DeviceEnergy-based vessel sealing device used to perform salpingo-oophorectomy.
Standard salpingo-oophorectomy technique
Procedure/SurgerySalpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices.
Duration of salpingo-oophorectomy procedure
Duration of the salpingo-oophorectomy procedure, measured from completion of the vaginal hysterectomy and the decision to proceed with salpingo-oophorectomy until removal of the fallopian tube and ovary specimen from the patient on the both sides.
Intraoperative blood loss
Blood loss during salpingo-oophorectomy, measured by weighing surgical pads used during the procedure
Postoperative pain
Postoperative pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain), as routinely used in the gynecology department, assessed at the evening of the day of surgery
Length of hospital stay
Duration of postoperative hospitalization measured from admission to the gynecology until discharge decision by the attending surgeon
Intraoperative and postoperative complications
Rate of intraoperative and postoperative complications related to the surgical procedure
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