Status:
COMPLETED
Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study
Lead Sponsor:
Karolinska Institutet
Conditions:
Prolapse; Female
Eligibility:
FEMALE
18-99 years
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, prospect...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03878056
Start Date
January 1 2018
End Date
November 30 2021
Last Update
April 8 2022
Active Locations (1)
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1
Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital
Stockholm, Sweden, 18288