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Study Title and Description

Tension-free vaginal tape operation: results of the Austrian registry.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Tension-free vaginal tape operation: results of the Austrian registry.
Author Tamussino KF, Hanzal E, K├Âlle D, Ralph G, Riss PA
Country Department of Obstetrics and Gynecology, University of Graz, Austria.
Year 2001
Numbers 24 (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 Retropubic synthetic TVT (Ethicon)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective Cohort (all received same sling)
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Study Country Austria
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Sling Category Retropubic synthetic
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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 ... Other ... 55 centers, unclear number of surgeons
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Passive
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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) This are the results of the Austrian registry on TVT. The registry started in 1998. All 95Gyn departments in Austria were contacted via mail regarding participation in the registry. A total of 55 units entered 2795 patients.
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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
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation not reported In hospital no 75
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Retropubic synthetic Increased bleeding Increased bleeding perioperatively not reported In hospital No 65
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Total
Retropubic synthetic Return to OR Reoperation attributtable to TVT operation not reported yes 68
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Retropubic synthetic Infection, UTI not reported no 486
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