Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy
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|ClinicalTrials.gov Identifier: NCT02741830|
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 10, 2019
|Condition or disease|
|Pelvic Organ Prolapse|
Pelvic organ prolapse is a common problem affecting many women and there is a 12.6% lifetime risk of undergoing reconstructive pelvic surgery. There are several surgical options available to patients undergoing reconstruction for pelvic organ prolapse, however addressing the apex is recommended to achieve the most durable outcomes. Two of the most commonly performed procedures for apical prolapse repair are uterosacral ligament suspension and robotic sacrocolpopexy.
High uterosacral ligament suspension is a native tissue repair which is performed by affixing the vaginal apex to the bilateral uterosacral ligaments using permanent or delayed-absorbable sutures. This is performed typically in a vaginal approach. Sacrocolpopexy is a performed by attaching the anterior and posterior vaginal walls to the sacral promontory using synthetic mesh, typically polypropylene. This procedure can be performed by an abdominal approach, a laparoscopic approach or with the assistance of the da Vinci robotic system. In recent years, robotic sacrocolpopexy has largely replaced the abdominal approach, and become the procedure of choice for minimally invasive surgeons.
Most studies evaluating sacrocolpopexy outcomes were performed prior to the popularity of robotics and therefore concentrate on abdominal sacrocolpopexy.
This cross sectional, two cohort study will compare outcomes of uterosacral ligament suspension versus robotic sacrocolpopexy and will give pelvic surgeons a better understanding about the durability of these procedures, and possible longer term complication rates.
Subjects will be contacted and asked to come to the office for a visit and completion of questionnaires. If they cannot come to the office, an Informed Consent Form (ICF) and questionnaires will be mailed to them to complete and return separately.
|Study Type :||Observational|
|Actual Enrollment :||186 participants|
|Official Title:||Long Term Outcomes of Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy|
|Actual Study Start Date :||April 7, 2016|
|Actual Primary Completion Date :||May 21, 2018|
|Actual Study Completion Date :||October 16, 2018|
Uterosacral ligament suspension (USLS)
This group of patients underwent the procedure of native tissue vaginal reconstructive surgery using uterosacral ligament suspension for pelvic organ prolapse.
Robotic sacrocolpopexy (RSC)
This group of patients underwent the reconstructive pelvic surgery of robotic sacrocolpopexy using synthetic mesh.
- Subject patient symptoms of prolapse, "bulge" symptom [ Time Frame: 3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocolpopexy ]This is a binary outcome, and success is defined as answering "No" to question #3 on the Pelvic Organ Prolapse Distress Inventory (PFDI-20) questionnaire, as well as the absence of any reoperation or pessary use for pelvic organ prolapsed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741830
|United States, Ohio|
|Cincinnati Urogynecology Associates|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Rachel Pauls, MD||TriHealth - Cincinnati Urogynecology Associates|