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| Name | Class |
|---|---|
| TriHealth Hatton Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vessel sealing device | Experimental | Vessel 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LigaSureTM vessel sealing device | Device | Device will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Visual Analog Scale, 0-10, with 10 being "most severe pain" | 3-6 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Pain | Visual Analog Scale, 0-10, with 10 being "most severe pain" | 3-6 hours postoperative |
| Abdominal Pain | Visual Analog Scale, 0-10, with 10 being "most severe pain" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Yeung, DO | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States | ||
| Bethesda North Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39657205 | Derived | 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. |
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Single-blinded randomized controlled trial
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Participant will be under anesthesia and will not know which surgical method is being utilized.
| 3-6 hours postoperative |
| Cincinnati |
| Ohio |
| 45242 |
| United States |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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