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Study Title and Description

Suburethral sling materials: Best outcome with autologous tissue



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Suburethral sling materials: Best outcome with autologous tissue
Author Simsiman AJ, Powell CR, Stratford RR, Menefee SA.
Country --
Year 2005
Numbers Pubmed ID: 16325625
15 (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 Fascial PVS Rectus or fascia lata
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2 Cadaveric PVS Use of cadaveric fascia for pubovaginal sling (allograft)
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3 Xenograft PVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective nonrandom (2+ slings analyzed separately)
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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 Community hospital
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No. of Surgeons Performing the Procedures ... Other ... 3 Attending surgeons
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Surgeons' Training Urogynecology
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Urology
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Residents or Fellows Performing the Surgery? Yes
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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) Retrospective and very little information provided about AEs or which AEs were looked for.
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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
Fascial PVS Obstruction requiring reoperation Prolonged postoperative voiding dysfunction or persistent irritative symptoms 23 ± 14 mo (mean ± SD) after discharge yes no 4 78 ND ND
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Cadaveric PVS 25 ± 14 mo after discharge 4 80
Xenograft PVS 17 ± 6 mo after discharge 2 83
Total
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Ureteral injury required reimplantation; likely related to concomitant uterosacral colpopexy 23 ± 14 mo (mean ± SD) unclear yes no 1 78 ND ND
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Cadaveric PVS 25 ± 14 mo 0 80
Xenograft PVS 17 ± 6 mo 0 83
Total
Fascial PVS Organ injury in OR (urethra, bladder, bowel) Cystotomies 23 ± 14 mo (mean ± SD) unclear 3 78
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Cadaveric PVS 25 ± 14 mo 1 80
Xenograft PVS 17 ± 6 mo 0 83
Total
Fascial PVS DVT DVT immediate postoperative period 1 78
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Cadaveric PVS unclear 0 80
Xenograft PVS 0 83
Total