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Study Title and Description

Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings
Author De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F.
Country --
Year 2010
Numbers Pubmed ID: 20204323
16 (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 Minisling obturator
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2 Transobturator synthetic
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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 France
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Other ... Belgium
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Sling Category Obturator synthetic
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Minisling H (obturator)
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Multicenter? Yes
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures ... Other ...
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Surgeons' Training Urology
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Other ... gynecology (not clear if specialty training)
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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 ... Other ... no conflicts of interest from authors
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Not reported
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Comments (overall study) Each technique was performed by different surgeons (any one surgeon peformed one procedure, not a combination of the studied procedures)
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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 catheter ND after discharge 3 75 ND 0.95
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Transobturator synthetic 3 56
Total
Minisling obturator Infection, UTI ND ND No ND 4 75 ND 0.96
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Transobturator synthetic 2 56
Total
Minisling obturator Pain, groin (new or different after surgery) ND after discharge yes ND 3 75 ND 1
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Transobturator synthetic 2 56
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Minisling obturator Bleeding > 500 mL ND In hospital yes ND 0 75 ND 0.42
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Transobturator synthetic 1 56
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Minisling obturator Organ injury in OR (urethra, bladder, bowel) Bladder perf ND ND yes ND 0 75 ND 1
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Transobturator synthetic 0 56
Total
Minisling obturator Mesh erosion/extrusion/exposure/granulation tissue erosion ND after discharge 0 75 ND 0.43
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Transobturator synthetic 1 56
Total