An interventional study of Elevate mesh and Sacrocolpopexy in Vaginal Vault Prolapse, Enterocele and Uterine Prolapse, sponsored by Francisco Carmona. Status unknown at 1 site in Spain. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Francisco Carmona · Not applicable, Interventional, and Treatment
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Francisco Carmona is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Contraindication
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The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.
Device: Elevate mesh
Sacrocolpopexy for the correction of the prolapse
Device: Sacrocolpopexy
The correction of the prolapse can be made by this new technique.
Also known as: Pelvic meshes
Attach a mesh between the vagina and the promontorium.
Also known as: Colpofixation
Functional and anatomical efficacy
Time frame: 1 year
operating time, cost and complications of both techniques
Time frame: 6 months
Plan to share: Yes — First article has been submitted to the European Urology on feb 13th 2017, was rejected. Article accepted for publishing in may 2018 in IUJ
The record gives a start of May 2010, a primary completion of Nov 2016 and a completion of Nov 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Francisco Carmona