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Study Title and Description

TVT SECUR System: Final results of a prospective, observational, multicentric study.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title TVT SECUR System: Final results of a prospective, observational, multicentric study.
Author Bernasconi F., Napolitano V., Natale F., Leone V., Lijoi D., Cervigni M.
Country Department of Obstetrics and Gynaecology, Desio Hospital, Desio, Italy.
Year 2012
Numbers Pubmed ID: 21887551
1465 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling obturator 110 patient underwent TVT-secur minisling in the H position
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2 Minisling retropubic 26 patient had TVT-secur minisling in the U position
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective nonrandom (2+ slings analyzed separately)
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Study Country Italy
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Sling Category Minisling H (obturator)
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Minsling U (retropubic)
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Multicenter? Yes
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Not reported
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Active
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding Not reported
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Comments (overall study) Prospective study comparing the H and the U placement of TVT Secur minisling
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Follow-up time In-hospital or After discharge Is event serious? Reported definition of serious event Number affected Number at risk (analyzed) Difference between 2 slings (eg, OR/RR or %, with 95% CI) Reported P value between slings Comments
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue Only totals were avilable
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Minisling retropubic
Total Intraoperative after ? None 2 123
Minisling obturator Obstruction requiring reoperation catheterization, only totals were avilable
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Minisling retropubic
Total after ? None 8 136
Minisling obturator Pain, groin (new or different after surgery) pain in obturator region Intraoperative after ? None 1 110
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Minisling retropubic Intraoperative after ? None 0 26
Total
Minisling obturator Retropubic hematoma Intraoperative In hospital ? None 0 110
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Minisling retropubic Intraoperative In hospital 1 26
Total
Minisling obturator Introperative Bleeding>200 cc Introperative Bleeding>200 cc, only otal numbers
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Minisling retropubic
Total Intraoperative IN hospital ? None 5 136
Minisling obturator accidental displacement ??, only totals
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Minisling retropubic
Total INtraoperative In hospital ? None 2 136
Minisling obturator Vaginal laceration Extensive vaginal laceration Intraoperative In Hospital ? None 1 136
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Minisling retropubic
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