Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

NCT ID: NCT02741830

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 186 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-07
• Study Completion Date: 2018-10-16

Brief 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.

Detailed 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.

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Robotic sacrocolpopexy (RSC)

This group of patients underwent the reconstructive pelvic surgery of robotic sacrocolpopexy using synthetic mesh.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 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, Crisp CC, Kleeman SD, Yook E, Pauls RN. Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy for Treatment of Apical Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):93-98. doi: 10.1097/SPV.0000000000000704.

Reference Type: DERIVED

PMID: 30807407 (View on PubMed)

Other Identifiers

16-003

Identifier Type: -

Identifier Source: org_study_id