Uterosacral Ligament Suspension Clip

Not Applicable

Completed

Conditions: Pelvic Organ Prolapse

Interventions: Device: Vascular Clip

Registration Number: NCT02700997

Lead Sponsor: TriHealth Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vascular clip	Vascular Clip	Application of a clip to dissolvable sutures.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures