Pelvic Organ Prolapse
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVascular 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
Sponsors
TriHealth Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* women aged 18-85 with pelvic organ prolapse (POP) who have elected uterosacral ligament suspension (USLS) for treatment
Exclusion criteria
* contraindication to computed tomography (CT), or intravenous (IV) contrast * those with claustrophobia * previous POP surgery * previous pelvic surgery to the fallopian tubes, ovaries, or rectum * previous pelvic radiation * known pelvic inflammatory disease or endometriosis * those with preexisting ureteral or vascular pathology or sacral anatomic abnormality * those with connective tissue disorders * those with preexisting neuropathy, chronic lower extremity pain disorders, or neurological disorders * those with renal anomalies such as pelvic kidney, duplication of the collecting system, prior nephrectomy * those with allergy to titanium * removal of the uterosacral sutures due to ureteral obstruction intraoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suture Location in Relation to the Surrounding Anatomy | 1 day after surgery | Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not undergo CT imaging | 1 |
| Overall Study | No CT measurement - pelvic calcification | 1 |
Baseline characteristics
| Characteristic | Vascular Clip |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 14.2 |
| BMI | 28 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Suture Location in Relation to the Surrounding Anatomy
Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.
Time frame: 1 day after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Internal iliac complex from right proximal suture | 2.5 cm | Standard Deviation 0.5 |
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Internal iliac complex from left proximal suture | 2.8 cm | Standard Deviation 0.7 |
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Right ureter from right proximal suture | 2.2 cm | Standard Deviation 0.5 |
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Right ureter from right distal suture | 2.2 cm | Standard Deviation 0.4 |
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Left ureter from left proximal suture | 2.4 cm | Standard Deviation 0.6 |
| Vascular Clip | Suture Location in Relation to the Surrounding Anatomy | Left ureter from left distal suture | 2.5 cm | Standard Deviation 0.6 |