Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:April 7, 2016
End Date:October 16, 2018

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Long Term Outcomes of Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy

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.

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.

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
We found this trial at
1
site
Cincinnati, Ohio 45220
Phone: 513-853-4213
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mi
from
Cincinnati, OH
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