Uterosacral Ligament Suspension Clip

NCT ID: NCT02700997

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-06-06

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vascular clip

Application of a clip to dissolvable sutures.

Group Type: EXPERIMENTAL

Vascular Clip

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Clip

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30180050 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-092

Identifier Type: -

Identifier Source: org_study_id