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

January 26, 2026 updated by: Michael Babin, Wolfson Medical Center

Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vaginal hysterectomy is a common surgical procedure performed for benign gynecologic indications, including pelvic organ prolapse. Opportunistic salpingectomy, with or without oophorectomy, is increasingly recommended at the time of hysterectomy in women at average risk for ovarian cancer, as it may reduce future cancer risk without increasing surgical morbidity. During vaginal hysterectomy, salpingo-oophorectomy can be performed using a conventional surgical technique involving clamping, cutting, and suturing, or by using energy-based vessel sealing devices.

Energy-based devices, such as the LigaSure Maryland, have been shown in other gynecologic procedures to reduce operative time, blood loss, and length of hospital stay. However, there are limited data comparing energy-based versus conventional techniques specifically for opportunistic salpingo-oophorectomy performed during vaginal hysterectomy.

This prospective, randomized controlled study is designed to compare an energy-based technique using the LigaSure Maryland device with a standard "knot-and-cut" technique for opportunistic salpingo-oophorectomy during vaginal hysterectomy for benign indications.

Women scheduled to undergo vaginal hysterectomy for pelvic organ prolapse, for whom salpingo-oophorectomy is recommended according to standard clinical indications, will be eligible for participation. After providing informed consent, participants will be randomly assigned to one of two parallel groups. In the intervention group, salpingo-oophorectomy will be performed using the LigaSure Maryland energy-based vessel sealing device. In the control group, salpingo-oophorectomy will be performed using the standard surgical technique of clamping, cutting, and suturing.

Randomization will be performed prior to surgery using a computerized randomization tool. Participants will be blinded to the surgical technique used. Surgeons will not be blinded due to the nature of the interventions.

The primary outcome of the study is the 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 on both sides. Secondary outcomes include estimated blood loss during the procedure, postoperative pain assessed using a visual analog scale (VAS), length of postoperative hospital stay, and the rate of intraoperative and postoperative complications.

Both surgical techniques are considered standard of care and are commonly used in modern gynecologic surgery. Patient safety is not expected to be compromised by participation in either study group. In cases where deviation from the assigned surgical technique is required intraoperatively due to anatomical or technical considerations, the participant will be excluded from the final analysis to avoid bias.

The results of this study aim to provide evidence regarding the safety and efficacy of energy-based opportunistic salpingo-oophorectomy during vaginal hysterectomy and may help guide surgical decision-making in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Holon, Israel
        • Recruiting
        • Wolfson Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Technique group
Salpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy.
Procedure: Standard salpingo-oophorectomy technique
Salpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices.
Experimental: LigaSure Maryland group
Salpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy
Device: LigaSure MaryLand
Energy-based vessel sealing device used to perform salpingo-oophorectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of salpingo-oophorectomy procedure
Time Frame: From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery
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.
From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery
Blood loss during salpingo-oophorectomy, measured by weighing surgical pads used during the procedure
From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery
Postoperative pain
Time Frame: Within 24 hours after surgery
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
Within 24 hours after surgery
Length of hospital stay
Time Frame: From admission to the gynecology ward after surgery until hospital discharge, assessed over approximately 1-5 days
Duration of postoperative hospitalization measured from admission to the gynecology until discharge decision by the attending surgeon
From admission to the gynecology ward after surgery until hospital discharge, assessed over approximately 1-5 days
Intraoperative and postoperative complications
Time Frame: From surgery to 30 days after surgery
Rate of intraoperative and postoperative complications related to the surgical procedure
From surgery to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0119-24-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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