Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07379411

Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - Comparing LigaSure Maryland Device to Conventional Knot-and-cut Approach

Led by Wolfson Medical Center · Updated on 2026-01-30

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods for removing the fallopian tubes and ovaries during vaginal hysterectomy in women with pelvic organ prolapse. The study aims to evaluate whether an energy-based device called LigaSure Maryland is as safe or more effective than the standard surgical approach of clamping, cutting, and suturing. This randomized controlled study focuses on procedure duration, blood loss, pain after surgery, hospital stay length, and complication rates. Participants will be randomly assigned to one of two groups: one group will undergo salpingo-oophorectomy using the LigaSure Maryland energy-based vessel sealing device, while the other group will receive the standard surgical technique. The removal of fallopian tubes and ovaries will be decided before surgery based on medical guidelines. Surgeons will know which technique is used, but participants will not. During the study, participants will be monitored for the time taken to complete the salpingo-oophorectomy, estimated blood loss, pain levels within 24 hours after surgery, length of hospital stay, and any surgical complications up to 30 days after the operation. Data will be analyzed only for those whose surgery follows the assigned technique. The total hospital stay is expected to be between 1 to 5 days, with the procedure lasting about 5 to 30 minutes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 approach
  • Intraoperative need to deviate from the assigned surgical technique due to anatomical or technical considerations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 to 5 days

Participants undergo vaginal hysterectomy with opportunistic salpingo-oophorectomy using either an energy-based device or the standard surgical technique. The procedure duration is approximately 5 to 30 minutes for the salpingo-oophorectomy part. Postoperative pain and complications are monitored within 24 hours after surgery.

1 hospital stay from admission to discharge

Post-operative Follow-up

Duration - 30 days

Participants are monitored for intraoperative and postoperative complications up to 30 days after surgery.

Follow-up visits or contacts as scheduled up to 30 days

Trial Site Locations

Total: 1 location

1

Wolfson Medical Center

Holon, Israel

Actively Recruiting

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Research Team

M

Michael Babin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial