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Study Title and Description

Osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery: report from single largest prospective series and literature review.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery: report from single largest prospective series and literature review.
Author Frederick RW., Carey JM., Leach GE.
Country Tower Urology Institute for Continence, Los Angeles, California 90048, USA.
Year 2004
Numbers Pubmed ID: 15491696
1237 (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 Cadaveric transvaginal sling with bone anchor fixation
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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 US
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Sling Category ... Other ... Cadaveric transvaginal sling with bone anchor fixation
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Multicenter? No
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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 Urology
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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 Not reported
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Comments (overall study) This study is a retrospective cohort and a review of the literature specifically looking at reported cases of osteitis and osteomielitis following transvaginal slings with bone anchor fixation. They used solvent dehydrated nonfrozen cadaveric fascia lata.They had 485 patients in their database. 440 had the minimum accepted follow up of 3 months. They performed slings on 127 patients, and sling plus cadaveric prolapse repair with sling in 313 patients. The report only makes reference to osseus complications. They also performed a literature review from 1995 to 2003, and they reported 1 case of osteomyelitis. I did not include the results from the literature review in the AEs report.
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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
Cadaveric transvaginal sling with bone anchor fixation Pain, other (new or different after surgery) Pelvic pain, new onset 12 months After discharge No 6 440
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Total
Cadaveric transvaginal sling with bone anchor fixation Pubis Osteitis Clinical, radiographic criteria outlined in Table III 12 months After discharge Yes 2 440
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