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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
1256 (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, BMI less than 30
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2 Fascial PVS, BMI 30 or greater
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3 Cadaveric PVS, BMI less than 30
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4 Cadaveric PVS, BMI 30 or greater
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5 Transobturator synthetic, BMI less than 30
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6 Transobturator synthetic, 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 Retropubic biologic
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Obturator synthetic
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Pubovaginal (bladder neck)
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Multicenter? Yes
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Institution Type Academic 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 is a retrospective cohort study of 3 procedures for SUI: Autologous rectus fascia, acellular porcine dermis and TOT. They ensambled 6 groups (3 procedures and BMI <or>30). Minimum follow up was 12 months. In terms of AEs they did not find increase complications in obese women. Table 6 summarizes all AEs. Unfortunately they do not report the crude numbers but rather percentages.
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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, BMI less than 30 Total perioperative complications Data are given in percentages 12 months In-hospital no 2.1 (%) 94
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Fascial PVS, BMI 30 or greater 12 months In-hospital no 3 66
Cadaveric PVS, BMI less than 30 12 months In-hospital no 3.2 157
Cadaveric PVS, BMI 30 or greater 12 months In-hospital no 4.4 114
Transobturator synthetic, BMI less than 30 12 months In-hospital no 3.7 161
Transobturator synthetic, BMI 30 or greater 12 months In-hospital no 2.6 117
Total
Fascial PVS, BMI less than 30 Total perioperative complications lasting less than 30 days All complications resolved by day 30 1 month Both no 13.8 94
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Fascial PVS, BMI 30 or greater 1 month Both no 22.7 66
Cadaveric PVS, BMI less than 30 1 month Both no 15.3 157
Cadaveric PVS, BMI 30 or greater 1 month Both no 17.5 114
Transobturator synthetic, BMI less than 30 1 month Both no 9.3 161
Transobturator synthetic, BMI 30 or greater 1 month Both no 6 117
Total
Fascial PVS, BMI less than 30 Urinary Retention lasting less than 30 days Urinary retention resolved by day 30 1 month both no 3.2 94
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Fascial PVS, BMI 30 or greater 1 month both no 3.0 66
Cadaveric PVS, BMI less than 30 1 month both no 3.8 157
Cadaveric PVS, BMI 30 or greater 1 month both no 4.4 114
Transobturator synthetic, BMI less than 30 1 month both no 3.7 161
Transobturator synthetic, BMI 30 or greater 1 month both no 1.7 117
Total
Fascial PVS, BMI less than 30 Abdominal wound complications resolved by day 30 1 month both no 5.3 94
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Fascial PVS, BMI 30 or greater 1 month both no 12.1 66
Cadaveric PVS, BMI less than 30 1 month both no 1.3 157
Cadaveric PVS, BMI 30 or greater 1 month both no 3.5 114
Transobturator synthetic, BMI less than 30 1 month both no 0.6 161
Transobturator synthetic, BMI 30 or greater 1 month both no 0 117
Total
Fascial PVS, BMI less than 30 Delayed vaginal healing/extrusion Delayed vaginal healing/extrusion resolved by day 30 1 month both no 3.2 94
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Fascial PVS, BMI 30 or greater 1 month both no 4.5 66
Cadaveric PVS, BMI less than 30 1 month both no 7.0 157
Cadaveric PVS, BMI 30 or greater 1 month both no 7.9 114
Transobturator synthetic, BMI less than 30 1 month both no 5.0 161
Transobturator synthetic, BMI 30 or greater 1 month both no 1.7 117
Total
Fascial PVS, BMI less than 30 Total complications lasting 30 days or more Total complications 12 months After discharge no 14.9 94
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Fascial PVS, BMI 30 or greater 12 months After discharge no 7.6 66
Cadaveric PVS, BMI less than 30 12 months After discharge no 9.6 157
Cadaveric PVS, BMI 30 or greater 12 months After discharge no 7.9 114
Transobturator synthetic, BMI less than 30 12 months After discharge no 5.0 161
Transobturator synthetic, BMI 30 or greater 12 months After discharge no 1.7 117
Total
Fascial PVS, BMI less than 30 Urinary retention/Positional voiding lasting 30 days or more 12 months After discharge no 14.9 94
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Fascial PVS, BMI 30 or greater 12 months After discharge no 1.5 66
Cadaveric PVS, BMI less than 30 12 months After discharge no 6.4 157
Cadaveric PVS, BMI 30 or greater 12 months After discharge no 3.5 114
Transobturator synthetic, BMI less than 30 12 months After discharge no 3.1 161
Transobturator synthetic, BMI 30 or greater 12 months After discharge no 0 117
Total
Fascial PVS, BMI less than 30 Pain, other (new or different after surgery) Dyspareunia lasting 30 days or longer 12 months After discharge no 0 94
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Fascial PVS, BMI 30 or greater 12 months After discharge no 1.5 66
Cadaveric PVS, BMI less than 30 12 months After discharge no 2.5 157
Cadaveric PVS, BMI 30 or greater 12 months After discharge no 2.6 114
Transobturator synthetic, BMI less than 30 12 months After discharge no 0 161
Transobturator synthetic, BMI 30 or greater 12 months After discharge no 0 117
Total
Fascial PVS, BMI less than 30 Total non-urological complications Unspecified 12 months ? no 2.1 94
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Fascial PVS, BMI 30 or greater 12 months ? no 1.5 66
Cadaveric PVS, BMI less than 30 12 months ? no 3.2 157
Cadaveric PVS, BMI 30 or greater 12 months ? no 0.9 114
Transobturator synthetic, BMI less than 30 12 months ? no 1.2 161
Transobturator synthetic, BMI 30 or greater 12 months ? no 1.7 117
Total
Fascial PVS, BMI less than 30 Total hospital readmissions Hospital readmissions 12 months After discharge no 6.4 94
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Fascial PVS, BMI 30 or greater 12 months After discharge no 3.0 66
Cadaveric PVS, BMI less than 30 12 months After discharge no 1.3 157
Cadaveric PVS, BMI 30 or greater 12 months After discharge no 0 114
Transobturator synthetic, BMI less than 30 12 months After discharge no 1.2 161
Transobturator synthetic, BMI 30 or greater 12 months After discharge no 1.7 117
Total
Fascial PVS, BMI less than 30 Total reoperations Total reoperations 12 months Both no 13.8 94
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Fascial PVS, BMI 30 or greater 12 months Both no 3 66
Cadaveric PVS, BMI less than 30 12 months Both no 1.3 157
Cadaveric PVS, BMI 30 or greater 12 months Both no 0 114
Transobturator synthetic, BMI less than 30 12 months Both no 1.2 161
Transobturator synthetic, BMI 30 or greater 12 months Both no 1.7 117
Total
Fascial PVS, BMI less than 30 Obstruction requiring reoperation Urethrolysis/sling incision 12 months Both no 7.4 94
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Fascial PVS, BMI 30 or greater 12 months Both no 0 66
Cadaveric PVS, BMI less than 30 12 months Both no 0.6 157
Cadaveric PVS, BMI 30 or greater 12 months Both no 0.9 114
Transobturator synthetic, BMI less than 30 12 months Both no 1.2 161
Transobturator synthetic, BMI 30 or greater 12 months Both no 0 117
Total