Uterosacral Ligament Suspension Clip

Pelvic Organ Prolapse Clinical Trial

— USLS  

Official title:

Uterosacral Ligament Suspension: A Radiographic Study of Anatomy and Suture Location

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700997
• Other study ID #: 15-092
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 6, 2018

Study information

• Verified date: November 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 6, 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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