Clinical trial NCT03878056: Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study
Official title: Cost-effectiveness Analysis and Patient Safety After Apical Prolapse Surgery by Mesh Via Different Approaches; Vaginal or Robotic-assisted: Multicenter, Prospective Parallel Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse; Female
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with apical prolapse and suffering prolapse symptoms.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Posthysterectomy prolapse of the vaginal apex, with or without cystocele/rectocele, where the vaginal apex descends at least 50% of the total vaginal length
* Uterine prolapse, with or without cystocele/rectocele, where the leading edge of the cervix descends at least 50% of the total vaginal length and TVL minus point C= ≤ 2 cm
* Prolapse specific pelvic symptom of pelvic heaviness and/or vaginal bulging
* Reproductive years in the past (biologically or reproductive decision)
* Being able to make an informed consent on participation
* Physically and cognitively capable of participating in the required follow-up
* No exclusion criteria fulfilled

Exclusion Criteria:

* Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele/rectocele is present or not
* Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
* If cervix elongation is present corresponding to: TVL minus point C= \>2 cm without uterine prolapse.
* If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
* Previous or current pelvic organ cancer (regardless of treatment)
* Severe rheumatic disease
* Insulin treated severe diabetes mellitus
* Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis or rheumatic myalgia)
* Current systemic steroid treatment
* Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence.
* Decision to perform prolapse surgery using other medical devices/mesh

Primary outcomes:
measure: Cost-effectiveness measurements and comparison between vaginal and robotic mesh surgery for apical prolapse
timeFrame: Changes from baseline an up to 1, 5 and 10 years
Secondary outcomes:
measure: Measurement of anatomical outcomes by Pelvic Organ Prolapse Quantification system (POP-Q): vaginal mesh utero-/colpopexy vs Robotic Sacral Colpopexy
timeFrame: Changes from baseline an up to 3 months, 1, 5 and 10 years
measure: Measurement of generic quality of Life (QoL) by The 15D instrument of health-related quality of Life (15D): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of pelvic floor symptoms by Pelvic Floor Distress Inventory (PFDI-20): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Ultrasound measurement of mesh length in cm and mapping of mesh in correlation to bladder and urethra: vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Ultrasound measurements at 1, 5 and 10 years after surgery
measure: Measurement of generic QoL by health related quality of life by EuroQol 5-dimensions questionnaire (EQ-5D): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of life impact in women with pelvic floor disorders by Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of sexual function by Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
measure: Measurement of patient recommendation to other patients to undergo same surgery if they suffer apical prolapse (assessed by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
timeFrame: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital
Study officials:
affiliation: Karolinska Institutet Danderyds Sjukhus (KIDS)
name: Edward Morcos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: