Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

Long Term Outcomes of Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741830
• Other study ID #: 16-003
• Status: Completed
• Start date: April 7, 2016
• Est. completion date: October 16, 2018

Study information

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

Clinical Trial Summary

This cross sectional, two cohort study seeks to investigate both anatomic outcome and subjective, functional outcome of uterosacral ligament suspension versus robotic sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and complication rate for each procedure.This study will provide a better understanding about the durability of these procedures and long term complication.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 16, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women aged 18 years of age or older who spent 3-7 years following uterosacral ligament suspension or robotic sacrocolpopexy.

• Concurrent procedures such as suburethral sling, bilateral salpingoophorectomy, hysterectomy, rectopexy.

• Concurrent procedures such a s takedown of sling

Exclusion Criteria:

• Concurrent procedure to remove vaginal mesh at time of their index surgery

• Unwillingness to participate in the study

• Dementia or inability to provide informed consent

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

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	Subject patient symptoms of prolapse, "bulge" symptom	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.	3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocolpopexy