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Study Title and Description

Bleeding complications with the tension-free vaginal tape operation.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Bleeding complications with the tension-free vaginal tape operation.
Author Kolle D, Tamussino K, Hanzal E, Tammaa A, Preyer O, Bader A, Enzelsberger H, Ralph G, Riss P
Country Austrian Urogynecology Working Group.
Year 2005
Numbers Pubmed ID: 16325613
1530 (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
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective Cohort (all received same sling)
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Study Name Bleeding complications after TVT
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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 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 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) Only focuses on bleeding related to TVT procedures; high numbers of patients included
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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 Transfusion post-op not listed not listed yes not listed 19 5578 n/a n/a
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Retropubic synthetic hematoma not listed not listed not listed not listed 5 5578 n/a n/a
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Retropubic synthetic increased intraop bleeding not further defined not listed not listed not listed not listed 106 5578 n/a n/a
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Retropubic synthetic external iliac artery laceration up to 2 days post op not listed yes not listed 5 5578 n/a n/a
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Retropubic synthetic Return to OR for bleeding related complications: 0-56 days after surgery in hospital and after discharge yes not listed 45 5578 n/a n/a
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Retropubic synthetic Death not listed not listed yes not listed 0 5578 n/a n/a
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