Clinical trial NCT05969067: Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
Official title: Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Sacrocolpopexy
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 assisted sacrocolpopexy (RA SCP).

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 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

Eligibility criteria: 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)

Primary outcomes:
measure: Operative Time (minutes)
timeFrame: Intraoperative time
Secondary outcomes:
measure: POP-Q exam
timeFrame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
measure: Pelvic Floor Distress Inventory PFDI-20
timeFrame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
measure: Pelvic Floor Impact Questionnaire PFIQ-7
timeFrame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
measure: Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12
timeFrame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
measure: Patient Global Impression of Improvement PGI-I
timeFrame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
measure: Decision Regret Scale (DRS)
timeFrame: 6 weeks postoperatively and 12 weeks postoperatively
measure: Satisfaction with Decision Scale (SDS)
timeFrame: 6 weeks postoperatively and 12 weeks postoperatively
measure: Clavien-Dindo classification for operative complication
timeFrame: 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch Galveston
state: Texas
Study officials:
affiliation: UTMB
name: Gokhan Kilic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
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