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Study Title and Description

Perioperative complications and early follow-up with 100 TVT-SECUR procedures



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Perioperative complications and early follow-up with 100 TVT-SECUR procedures
Author Neuman M.
Country --
Year 2008
Numbers Pubmed ID: 18539095
1844 (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 TVT-Secur
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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 ... Other ... Israel
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Sling Category Minisling H (obturator)
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Multicenter? Unclear/Not reported
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Institution Type Community hospital
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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 Unclear/Not reported
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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 ... Other ... Sole author was a TVT-S trainer for Ethicon.
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Comments (overall study) AEs likely passively collected. Definitions of AEs not provided, making it difficult to understand nuances between text and tables. "extrusion" and "protrusion" of mesh were both described, but the numbers in tables and text do not agree, which is confusing. BOO described, but later report "no postoperative outlet obstruction."
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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 Tape removal Unintended tape removal at time of inserter removal, requiring use of 2nd device 12 months in hospital no (but expensive) none 5 100 NA NA
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Total
Minisling obturator Vaginal wall perforation Tape perforated vaginal wall intraoperatively, requiring vaginal wall repair 12 months in hospital no (unless they all subsequently erode) none 4 100 NA NA
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Total
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue Describe only as "vaginal tape protrusion" and separately indicate "extrusion", but do not define either. 12 months assume after discharge yes none 10 100 NA NA
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Minisling obturator Bladder outlet obstruction no further details available 12 months not stated depends on severity none 2 100 NA NA
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Minisling obturator Dyspareunia not defined 12 months after discharge yes none 1 100 NA NA
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Minisling obturator Hematoma paravesical hematoma, no transfusion required 12 months unclear yes none 1 100 NA NA
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Minisling obturator Organ injury in OR (urethra, bladder, bowel) 12 months unclear yes none 0 100 NA NA
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Minisling obturator
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