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Study Title and Description

Is obesity a risk factor for failure and complications after surgery for incontinence and prolapse in women?



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Is obesity a risk factor for failure and complications after surgery for incontinence and prolapse in women?
Author Haverkorn RM., Williams BJ., Kubricht WS., Gomelsky A.
Country Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
Year 2011
Numbers Pubmed ID: 21247603
8046 (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 Transobturator synthetic monarc in BMI less than 30
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2 Xenograft PVS pelvicol in BMI less than 30
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3 Fascial PVS, BMI 30 or greater autologous rectus fasia
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4 Fascial PVS, BMI less than 30 autologos rectus fascia
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5 Transobturator synthetic Monarc in BMI 30 or greater
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6 Xenograft PVS pelvicol in BMI 30 or greater
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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 Obturator synthetic
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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 ...
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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) obese women have significantly lower SUI cure rates but complication rates were not increased and many have fewer voiding dysfunction compared to women with BMI less than 30
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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
Transobturator synthetic urinary retention not requiring surgery % postop less than 30 days 3.7 161 NS
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Xenograft PVS 3.8 157 NS
Fascial PVS, BMI 30 or greater 3.0 66 NS
Fascial PVS, BMI less than 30 3.2 94 NS
Transobturator synthetic 1.7 117 NS
Xenograft PVS 4.4 114 NS
Total
Transobturator synthetic Infection, surgical site/wound % postop less than 30 days abdominal wound complication 0.6 161 NS
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Xenograft PVS 1.3 157
Fascial PVS, BMI 30 or greater 12.1 66
Fascial PVS, BMI less than 30 5.3 94
Transobturator synthetic 0 117
Xenograft PVS 3.5 114
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue % postop less than 30 days delayed vaginal healing / extrusion 1.2 161 NS
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Xenograft PVS 7.0 157
Fascial PVS, BMI 30 or greater 4.5 66
Fascial PVS, BMI less than 30 3.2 94
Transobturator synthetic 2.6 117
Xenograft PVS 7.9 114
Total
Transobturator synthetic Retention requiring surgery % postop 30 days or more urethrolysis / sling incision 1.2 161
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Xenograft PVS 0.6 157
Fascial PVS, BMI 30 or greater 0 66
Fascial PVS, BMI less than 30 7.4 94 <0.001
Transobturator synthetic 0 117
Xenograft PVS 0.9 114
Total
Transobturator synthetic Pain, other (new or different after surgery) dyspareunia 0 161 NS
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Xenograft PVS 2.5 157
Fascial PVS, BMI 30 or greater 1.5 66
Fascial PVS, BMI less than 30 0 94
Transobturator synthetic 0 117
Xenograft PVS 2.6 114
Total
Transobturator synthetic Return to OR % postop 30 days or more urethrolysis / sling incision 7.5 161 NS
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Xenograft PVS 9.6 157
Fascial PVS, BMI 30 or greater 10.6 66
Fascial PVS, BMI less than 30 13.8 94
Transobturator synthetic 4.3 117
Xenograft PVS 7.9 114
Total
Transobturator synthetic non urologic complications 1.2 161 NS
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Xenograft PVS 3.2 157
Fascial PVS, BMI 30 or greater 1.5 66
Fascial PVS, BMI less than 30 2.1 94
Transobturator synthetic 1.7 117
Xenograft PVS 0.9 114
Total
Transobturator synthetic
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Xenograft PVS
Fascial PVS, BMI 30 or greater
Fascial PVS, BMI less than 30
Transobturator synthetic
Xenograft PVS
Total