Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02741830
Study type	Observational
Source	TriHealth Inc.
Contact
Status	Completed
Phase
Start date	April 7, 2016
Completion date	October 16, 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.