Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Wolfson Medical Center
RECRUITING
Holon
Contact Information
Primary
Michael Babin, MD
mckerko@gmail.com
972538535549
Time Frame
Start Date: 2025-10-16
Estimated Completion Date: 2027-09
Participants
Target number of participants: 70
Treatments
Active_comparator: Standard Technique group
Salpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy.
Experimental: LigaSure Maryland group
Salpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy
Sponsors
Leads: Wolfson Medical Center

This content was sourced from clinicaltrials.gov