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Study Title and Description

Use of synthetic material in sling surgery: a minimally invasive approach.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Use of synthetic material in sling surgery: a minimally invasive approach.
Author Norris JP, Breslin DS, Staskin DR.
Country Urodynamics and Continence Center, Beth Israel Hospital, Boston, MA, USA.
Year 1996
Numbers Pubmed ID: 8740383
1612 (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 Synthetic PVS Goretex patch sling
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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 Use of synthetic material in slings
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Study Country US
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Sling Category Pubovaginal (bladder neck)
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Multicenter? No
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Institution Type Academic 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 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) Poor reporting of perioperative AEs
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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
Synthetic PVS Retention requiring surgery cutting of sling due to persistent retention or "severe obstructive voiding symptoms" 12 weeks post op after discharge not listed not listed 6 122 n/a n/a
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Total
Synthetic PVS Mesh erosion/extrusion/exposure/granulation tissue exposure of goretex patch vaginally-requiring excision and reapproximation of vagina post op after discharge not listed not listed 5 122 n/a n/a
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Total
Synthetic PVS transient urinary retention used SP tube 1 week post op in hospital and after discharge not listed not listed 100 122 n/a n/a
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