Pelvic Organ ProlapseNCT05192954
Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery
A study testing LigaSureTM vessel sealing device in people with Pelvic Organ Prolapse, run by Marlana McDowell at 2 sites in United States.
Trial summary
This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- LigaSureTM vessel sealing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2022to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking, able to understand informed consent
- Vaginal hysterectomy with vaginal vault suspension
- with or without anterior and posterior repairs
- with or without removal of fallopian tubes or ovaries
- with or without procedures for stress urinary incontinence
Who cannot join
- Use of mesh for prolapse repair
- Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
- Concomitant procedure done by an additional surgeon
- Concomitant anal sphincteroplasty or rectovaginal fistula repair
- History of chronic pelvic pain receiving medical care
- Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
About this study
Official title: Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial
This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- LigaSureTM vessel sealing device
- Keywords
- Pelvic Organ Prolapse, Vaginal Hysterectomy, Vaginal Vault Suspension, Prolapse Repair
- 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.
LigaSureTM vessel sealing deviceDevice
Also called LigaSure, LigaSureTM, Electrosurgical sealing device
Device will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Vessel sealing device | Experimental | Vessel sealing device to be utilized for vaginal hysterectomy Receives: Device: LigaSureTM vessel sealing device |
| Conventional clamping and suturing method | No intervention | Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Visual Analog Scale, 0-10, with 10 being "most severe pain"
Measured: 3-6 hours postoperative
Secondary outcomes (2)
Vaginal Pain
Visual Analog Scale, 0-10, with 10 being "most severe pain"
Measured: 3-6 hours postoperative
Abdominal Pain
Visual Analog Scale, 0-10, with 10 being "most severe pain"
Measured: 3-6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start28 Jan 2022
- Primary completion30 Dec 2023
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- Model description
- Single-blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marlana McDowell
- Sponsor type
- University, hospital or other
- Collaborators
- TriHealth Hatton Research Institute
- Responsible party
- Sponsor-investigator, Marlana McDowell, TriHealth Inc.
- Investigators
- Jennifer Yeung, DO, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192954
- Sponsor's protocol ID
- 21-094
- Status last verified
- Nov 2024
- First submitted
- 29 Dec 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ray MM, Crisp CC, Pauls RN, Hoehn J, Lewis K, Bonglack M, Yeung J. Use of a Vessel Sealer for Hysterectomy at Time of Prolapse Repair: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):234-242. doi: 10.1097/SPV.0000000000001617. Epub 2024 Dec 9.
PubMed 39657205
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05192954
- Acronym / sponsor ID
- 21-094
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, Vaginal Hysterectomy, Vaginal Vault Suspension, Prolapse Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Marlana McDowellUniversity, hospital or other
- Collaborators
- TriHealth Hatton Research Institute
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 14 Jan 2022 (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 will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Vessel sealing device | Experimental | Device: LigaSureTM vessel sealing deviceVessel sealing device to be utilized for vaginal hysterectomy |
| Conventional clamping and suturing method | No intervention | –Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking, able to understand informed consent
- Vaginal hysterectomy with vaginal vault suspension
- with or without anterior and posterior repairs
- with or without removal of fallopian tubes or ovaries
- with or without procedures for stress urinary incontinence
Key exclusion criteria (7 listed)
- Use of mesh for prolapse repair
- Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
- Concomitant procedure done by an additional surgeon
- Concomitant anal sphincteroplasty or rectovaginal fistula repair
- History of chronic pelvic pain receiving medical care
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 |
|---|---|---|
| LigaSureTM vessel sealing deviceAlso: LigaSure, LigaSureTM, Electrosurgical sealing deviceDevice will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy. | Device | Vessel sealing device |
Primary outcome
Postoperative Pain
Time frame: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
2 secondary outcomes
Vaginal Pain
Time frame: 3-6 hours postoperative
Abdominal Pain
Time frame: 3-6 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 39657205Ray MM, Crisp CC, Pauls RN, Hoehn J, Lewis K, Bonglack M, Yeung J. Use of a Vessel Sealer for Hysterectomy at Time of Prolapse Repair: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):234-242. doi: 10.1097/SPV.0000000000001617. Epub 2024 Dec 9.
- 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. This study is not recruiting at the moment.
Jennifer Yeung, DO principal investigator
TriHealth Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LigaSureTM vessel sealing device in people with Pelvic Organ Prolapse, run by Marlana McDowell at 2 sites in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 3-6 hours postoperative). 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 NCT05192954, which also lists 1 linked publication.
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 22 Nov 2024.