Status:
COMPLETED
Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 assist...
Detailed Description
Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05969067
Start Date
August 10 2023
End Date
September 1 2024
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Medical Branch Galveston
Galveston, Texas, United States, 77554