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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 Research and Development in Urogynecology, Shaare Zedek Medical Center, Jerusalem and Urogynecology, Assuta Medical Centers, Rishon le-Zion and Tel-Aviv, Israel. mneuman@netvision.net.il
Year 2008
Numbers Pubmed ID: 18539095
Donshik 1998 Study 2 (pubmed)

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-Secure 100 consecutive cases
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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? Yes
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Institution Type ... Other ... private hospital operative theaters
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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 ... Other ... author was a TVT-Secure trainer for ethicon
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Comments (overall study) cystoscopy was not performed
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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 Obstruction requiring reoperation tape removal perioperative and 12 months f/u 5 100
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Total
Minisling obturator Organ injury in OR (urethra, bladder, bowel) vaginal wall perforation during placement intraoperative 4 100
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Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue 10 100
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Minisling obturator OAB UUI, urgency and frequency 21 100
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Minisling obturator Pain, other (new or different after surgery) dyspareunia 1 100
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Minisling obturator paravesical hematoma resolved spontanously 1 100
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