Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
NCT ID: NCT03034499
Last Updated: 2019-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-03-20
2019-04-01
Brief Summary
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1. Via single-port.
2. Via multi-port.
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Detailed Description
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1. Via single-port.
2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.
Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.
Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy.
Single-port sacrocolpopexy
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Multi-port sacrocolpopexy
Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy.
Multi-port sacrocolpopexy
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Interventions
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Single-port sacrocolpopexy
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Multi-port sacrocolpopexy
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients after previous surgical procedures for prolapse repair.
30 Years
80 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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ROY LAUTERBACH MD
Principal investigator
Principal Investigators
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Roy Lauterbach, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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References
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Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.
Other Identifiers
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0631-16-RMB
Identifier Type: -
Identifier Source: org_study_id
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