Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03878056
Study type Observational
Source Karolinska Institutet
Contact
Status Completed
Phase
Start date January 1, 2018
Completion date November 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04880239 - REDUCE Trial- Reducing Prolapse Recurrence N/A
Recruiting NCT05978414 - Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology N/A
Recruiting NCT05836844 - Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Not yet recruiting NCT06404931 - Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment Phase 2
Active, not recruiting NCT06128291 - Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair
Completed NCT06352112 - Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse N/A
Recruiting NCT04440475 - Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy N/A
Recruiting NCT05760794 - Barbed-suture Efficiency Study for Sacrocolpopexy N/A
Recruiting NCT05633901 - Impact of Preop Video on Patient Anxiety N/A
Completed NCT04491617 - STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial N/A
Recruiting NCT05750615 - What Affects Willingness to Self-manage a Pessary?
Not yet recruiting NCT06159777 - Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery Phase 4