Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).

Key facts

Study ID

NCT05969067

Run by

The University of Texas Medical Branch, Galveston

People needed

40

Starts

2023-08-10

Expected to finish

2024-09-01

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Females at least 18 years of age at the time of consent.
• Able to understand and read English
• Able and willing to provide written informed consent
• Able to comply with the follow-up study protocol, per clinician judgment
• Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.
• RA SCP as desired surgical approach to correct apical prolapse

You may not qualify if…

• Females who are pregnant, or intend to become pregnant during the study
• Texas Department of Criminal Justice prisoners
• A known history of sensitivity to propylene mesh
• Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)
• Active or chronic systemic infection including any pelvic infection, abscess
• Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
• Prior or current pelvic radiation, or chemotherapy.
• Not a candidate for general anesthesia
• History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)
• History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)

Where it is running

• University of Texas Medical Branch Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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