Pelvic Organ Prolapse (POP)NCT07379411
Are There Benefits of Using Energy-based Devices for Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy Compared to a Standard Cold Approach?
A study testing LigaSure MaryLand and Standard salpingo-oophorectomy technique in people with Pelvic Organ Prolapse (POP), run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP)
- What is being tested?
- LigaSure MaryLand and Standard salpingo-oophorectomy technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Michael Babin, MD, 972538535549, mckerko@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse (POP)
- Being tested
- LigaSure MaryLand, Standard salpingo-oophorectomy technique
- Keywords
- pelvic organ prolapse, vaginal surgery, vaginal hysterectomy, salpingo-oophorectomy, prophylactic salpingo-oophorectomy, vaginal salpingo-oophorectomy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSure MaryLandDevice
Energy-based vessel sealing device used to perform salpingo-oophorectomy.
Standard salpingo-oophorectomy techniqueProcedure or surgery
Salpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices.
| Study group | Role | What they receive |
|---|---|---|
| Standard Technique group | Active comparator | Salpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy. Receives: Procedure: Standard salpingo-oophorectomy technique |
| LigaSure Maryland group | Experimental | Salpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy Receives: Device: LigaSure MaryLand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery
Secondary outcomes (4)
Intraoperative blood loss
Blood loss during salpingo-oophorectomy, measured by weighing surgical pads used during the procedure
Measured: From completion of vaginal hysterectomy until completion of salpingo-oophorectomy, assessed over approximately 5-30 minutes during surgery
Postoperative pain
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
Measured: Within 24 hours after surgery
Length of hospital stay
Duration of postoperative hospitalization measured from admission to the gynecology until discharge decision by the attending surgeon
Measured: From admission to the gynecology ward after surgery until hospital discharge, assessed over approximately 1-5 days
Intraoperative and postoperative complications
Rate of intraoperative and postoperative complications related to the surgical procedure
Measured: From surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start16 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Babin, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379411
- Sponsor's protocol ID
- 0119-24-WOMC
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37672283Bonavina 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.
PubMed 38247214Antosh 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.
PubMed 28734829Kroft 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.
PubMed 22015881Lauterbach 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.
PubMed 35843545
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy-based Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy - is it Better Than Conventional "Knot-and-cut" Approach? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07379411
- Acronym / sponsor ID
- 0119-24-WOMC
- Conditions
- Pelvic Organ Prolapse (POP)
- Keywords
- pelvic organ prolapse, vaginal surgery, vaginal hysterectomy, salpingo-oophorectomy, prophylactic salpingo-oophorectomy, vaginal salpingo-oophorectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Technique group | Active comparator | Procedure: Standard salpingo-oophorectomy techniqueSalpingo-oophorectomy performed using the standard surgical technique of clamping, cutting, and suturing during vaginal hysterectomy. |
| LigaSure Maryland group | Experimental | Device: LigaSure MaryLandSalpingo-oophorectomy performed using the LigaSure Maryland energy-based vessel sealing device during vaginal hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LigaSure MaryLandEnergy-based vessel sealing device used to perform salpingo-oophorectomy. | Device | LigaSure Maryland group |
| Standard salpingo-oophorectomy techniqueSalpingo-oophorectomy performed using clamping, cutting, and suturing without the use of energy-based devices. | Procedure or surgery | Standard Technique group |
Primary outcome
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.
4 secondary outcomes
Intraoperative blood loss
Time frame: 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
Length of hospital stay
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publication: PubMed 37672283Kahn 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.
- Results publication: PubMed 38247214Bonavina 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.
- Results publication: PubMed 28734829Antosh 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.
- Results publication: PubMed 22015881Kroft 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.
- Results publication: PubMed 35843545Lauterbach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LigaSure MaryLand and Standard salpingo-oophorectomy technique in people with Pelvic Organ Prolapse (POP), run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Babin, MD (972538535549, mckerko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07379411, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.