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Study Title and Description

Comparison of autologous rectus fascia and cadaveric fascia in pubovaginal sling continence outcomes.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Comparison of autologous rectus fascia and cadaveric fascia in pubovaginal sling continence outcomes.
Author Howden NS, Zyczynski HM, Moalli PA, Sagan ER, Meyn LA, Weber AM
Country Division of Urogynecology, Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Pittsburgh Health Sciences Center, Magee-Womens Hospital, Pittsburgh, PA, USA.
Year 2006
Numbers 11 (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 Autologous rectus fascia
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2 Cadaveric PVS Use of cadaveric fascia for pubovaginal sling
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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 Academic hospital
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No. of Surgeons Performing the Procedures ... Other ... 5 (4 urogyn and 1 urologist)
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Surgeons' Training Urogynecology
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Urology
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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 Academia
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Comments (overall study) This is a retrospective cohort of autologous versus cadaveric pubovaginal slings. Cohorts were ensambled by periods of time, reflecting the authors' practices at the time: autologous fascia use between 1994-98 and use of cadaveric fascia 1998-2003. Of 1069 women contacted by mail, 630 responded and 308 were enrolled (28.8%). Perioperative AEs ascertainment was based on chart review, and limited to blood loss/transfusion. The majority of the data presented is in regards to recurrence of SUI or need for reoperation due to failure. There is no information regarding reoperation regarding obstructive symptoms. Results favor autologous fascia. Unfortunately there is very little data regarding AEs that could be extracted. Only number I could extract was the number of blood transfusions (5 vs 1), however given the poor follow up rate, <30% this should be interpreted with caution. [Note: all patients with blood transfusions had concomitant hysterectomy, reconstructive pelvic surgery or both. Not clear what bleeding was due/related to.]
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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 Transfusion post-op Postoperative blood transfusion 7.1 years In hospital 1
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Cadaveric PVS 3.5 years In hospital 5
Total 6
Fascial PVS Return to OR Reoperation, from wording I presume due to failure 7.1 years After discharge yes no 1 153 <0.0003
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Cadaveric PVS 3.5 years After discharge 4 150
Total