NCT03878056

Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study

Cost-effectiveness Analysis and Patient Safety After Apical Prolapse Surgery by Mesh Via Different Approaches; Vaginal or Robotic-assisted: Multicenter, Prospective Parallel Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery. A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients.

Detailed description

Pelvic organ prolapse (POP) is a common condition and may be disabling and limiting quality of life (QoL) among aging women. POP may arise in the anterior (cystocele), posterior (rectocele) and middle compartment (apical POP) of the vagina. Apical POP includes descent of uterus or vaginal vault (if uterus was previously removed). The lifetime risk of undergoing a single operation for POP or urinary incontinence by age 80 is 11%. In Sweden, the risk to undergo 2 pelvic floor surgery is about 130 000 women. Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present (ca 60%). Thus, minimal invasive surgical approaches by apical trans-vaginal mesh (A-TVM) and robotic sacral colpopexy (RSC) to support the vaginal apex (middle compartment) are in progress. 1 Evidence show effectivity and improved QoL after surgery. Vaginal and robotic accesses may be available to many patients. Vaginal approach may allow surgeon to perform surgery for all POP compartments and perineal injury in one single surgery opportunity. Contra-indications for general anesthesia and some abdominal diseases or conditions may dismiss the robotic surgery. In contrast, all patients can be operated via the vaginal approach except for patient unwellness. Thus, a direct low cost of vaginal surgery may be possible. In the other hand, costs for robotic surgery are high. Whether or not this may be reflected on cost-effectiveness based on QoL improvement after surgery has not yet been studied. Visualising synthetic implants i.e. POP mesh and the Tension-Free Vaginal Tape (TVT) implant for urinary incontinence (UI) by ultrasonography (US) has been a subject for some studies. Using US, localisation of the TVT in correlation to urinary bladder neck and how close to urethra may explain outcomes after TVT surgery. Given its importance, knowledge of how mesh anatomical position may influence outcomes, it may be useful in further POP surgery development. Our results indicate that US can be used and is reproducible in mapping of A-TVM (manuscript). Growing need worldwide is to have more cost-effective and safe health care. Cost-effectiveness, safety, outcomes, POP-recurrence and effects on pelvic floor dysfunction have not yet been directly compared between vaginal and robotic mesh surgery for apical POP. Topic: Cost-Effectiveness (Vaginal vs robotic POP mesh surgery), QoL, safety and outcomes.

Conditions

• Prolapse; Female

Interventions

Type	Name	Description
DEVICE	Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific	Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-31
• Completion: 2021-11-30
• First posted: 2019-03-18
• Last updated: 2022-04-08

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study