Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

The University of Texas System (UT)

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Dissection Technique during RA SCP; Procedure: Tunneling Technique during RA SCP

Study type: Interventional

Funder types: Other

Identifiers

NCT05969067

23-0124

Details and patient eligibility

About

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).

Full 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 determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Dissection Technique

Placebo Comparator group

Description:

The peritoneum is incised superficially and opened longitudinally from the sacral promontory, downward to the posterior cul-de-sac and the posterior vaginal wall to create retroperitoneal space for the SCP mesh.

Treatment:

Procedure: Dissection Technique during RA SCP

Tunneling Technique

Experimental group

Description:

A retroperitoneal tunnel is created by undermining the peritoneum with the robotic scissors and/or needle driver which is placed in the peritoneal opening over the sacral promontory. The tunnel is created just medial to the right uterosacral ligament and toward the posterior vaginal wall by using forward pressure and a sweeping motion to create a space within the retroperitoneum

Treatment:

Procedure: Tunneling Technique during RA SCP