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This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. Characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.
Uterosacral ligament suspension Is a commonly performed procedure to support the vaginal apex at the time of pelvic reconstructive surgery for pelvic organ prolapse (POP). Despite being a well established durable option for patients, there is little research detailing ligament suspension suture location in the living model. The available literature is limited to cadaveric studies, which suggest suture placement is in close proximity to vital structures such as the ureter, blood vessels, rectum and nerves.
This study seeks to describe suture location in relation to the surrounding anatomy in postoperative patients following high uterosacral ligament suspension. The secondary aim is to determine safe zones for suture placement.
Seventeen women (aged 18-85) under the care of Cincinnati Urogynecology Associates, a physician group of TriHealth, who have chosen vaginal hysterectomy with uterosacral ligament suspension (USLS) as the treatment choice for pelvic organ prolapse (POP) will be enrolled.
At the time of surgery, a titanium vascular clip (size small) will be applied to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging.
On postoperative day (POD) 1, patients will undergo CT pelvis scans. The CT scan will involve administration of IV contrast for imaging of the ureters and vascular structures. The clip will fall off when the sutures dissolve at 12 weeks postoperatively. All patients will be asked to complete a lower extremity neurological questionnaire preoperatively and postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascular clip | Experimental | Application of a clip to dissolvable sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Clip | Device | Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Suture Location in Relation to the Surrounding Anatomy | Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture. | 1 day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Urogynecology Associates | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30180050 | Derived | Smith BC, Herfel CV, Yeung J, Shatkin-Margolis A, Crisp CC, Kleeman SD, Pauls RN. Uterosacral Ligament Suspension: A Radiographic Study of Suture Location in Live Subjects. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):541-545. doi: 10.1097/SPV.0000000000000629. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vascular Clip | Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vascular Clip | Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suture Location in Relation to the Surrounding Anatomy | Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture. | Posted | Mean | Standard Deviation | cm | 1 day after surgery |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vascular Clip | Application of a clip to dissolvable sutures. Vascular Clip: Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Pauls MD | TriHealth Inc. | 513-463-4300 | Rachel_Pauls@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2016 | Sep 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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