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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?

RecruitingNAAges 18 Years - anyFemaleWolfson Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • LigaSure MaryLand
  • Standard salpingo-oophorectomy technique
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Where

1 site
Wolfson Medical Center
Holon, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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