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

NCT ID: NCT03878056

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-11-30

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.

Conditions

Prolapse; Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Transvaginal mesh

Vaginal surgery (UpholdTM Lite Vaginal Support, Boston Scientific)

Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Intervention Type: DEVICE

Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Robotic sacral colpopexy

Robotic surgery (Artisyn® Y-Shaped Mesh - Ethicon)

Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Intervention Type: DEVICE

Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Interventions

Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Intervention Type: DEVICE

Other Intervention Names

Robotic: Artisyn® Y-Shaped Mesh - Ethicon

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Edward Morcos

Principle investigator, Head of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Morcos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet Danderyds Sjukhus (KIDS)

Locations

Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Dnr: 2017/1988-31, 2018/380-32

Identifier Type: -

Identifier Source: org_study_id