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

NCT07379411 | Recruiting

• 1 other identifier: 0119-24-WOMC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

pelvic organ prolapse; vaginal surgery; vaginal hysterectomy; salpingo-oophorectomy; prophylactic salpingo-oophorectomy; vaginal salpingo-oophorectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery

Secondary Outcomes (4)

• Intraoperative blood loss

  From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery

• Postoperative pain

  Within 24 hours after surgery

• Length of hospital stay

  From admission to the gynecology ward after surgery until hospital discharge, assessed over approximately 1-5 days

• Intraoperative and postoperative complications

  From surgery to 30 days after surgery

Study Arms (2)

Standard Technique group

ACTIVE COMPARATOR

Salpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy.

Procedure: Standard salpingo-oophorectomy technique

LigaSure Maryland group

EXPERIMENTAL

Salpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy

Device: LigaSure MaryLand

Interventions

Standard salpingo-oophorectomy technique PROCEDURE

Salpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices.

Standard Technique group

LigaSure MaryLand DEVICE

Energy-based vessel sealing device used to perform salpingo-oophorectomy.

LigaSure Maryland group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

Related Publications (5)

• Kahn RM, Gordhandas S, Godwin K, Stone RL, Worley MJ Jr, Lu KH, Long Roche KC. Salpingectomy for the Primary Prevention of Ovarian Cancer: A Systematic Review. JAMA Surg. 2023 Nov 1;158(11):1204-1211. doi: 10.1001/jamasurg.2023.4164.

  PMID: 37672283 RESULT

• Bonavina G, Busnelli A, Salmeri N, Cavoretto PI, Salvatore S, Candiani M, Bulfoni A. Opportunistic salpingectomy at the time of vaginal hysterectomy: A systematic review and meta-analysis. Int J Gynaecol Obstet. 2024 Aug;166(2):494-501. doi: 10.1002/ijgo.15386. Epub 2024 Jan 21.

  PMID: 38247214 RESULT

• Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.

  PMID: 28734829 RESULT

• Kroft J, Selk A. Energy-based vessel sealing in vaginal hysterectomy: a systematic review and meta-analysis. Obstet Gynecol. 2011 Nov;118(5):1127-1136. doi: 10.1097/AOG.0b013e3182324306.

  PMID: 22015881 RESULT

• Lauterbach R, Gruenwald O, Matanes E, Justman N, Mor O, Vitner D, Avrahami R, Ghanem N, Zipori Y, Weiner Z, Lowenstein L. A randomized controlled trial of 2 techniques of salpingectomy during cesarean delivery. Am J Obstet Gynecol MFM. 2022 Nov;4(6):100690. doi: 10.1016/j.ajogmf.2022.100690. Epub 2022 Jul 16.

  PMID: 35843545 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Babin, MD

CONTACT

972538535549; mckerko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 30, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)