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Study Title and Description

Burch colposuspension versus fascial sling to reduce urinary stress incontinence.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Burch colposuspension versus fascial sling to reduce urinary stress incontinence.
Author Albo ME
Country --
Year 2007
Numbers Pubmed ID: 17517855
20084 (internal)

Secondary Publication Information
UI Title Author Country Year
Complications in women undergoing Burch colposuspension versus autologous rectus fascial sling for stress urinary incontinence Chai TC, Albo ME, Richter HE, Norton PA, Dandreo KJ, Kenton K, Lowder JL, Stoddard AM -- 2009
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Changes in urodynamic measures two years after Burch colposuspension or autologous sling surgery Kraus SR, Lemack GE, Richter HE, Brubaker L, Chai TC, Albo ME, Sirls LT, Leng WW, Kusek JW, Norton P, Litman HJ -- 2011
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Design of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) Tennstedt S -- 2005
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Quality of life after surgery for stress incontinence. Tennstedt SL, Litman HJ, Zimmern P, Ghetti C, Kusek JW, Nager CW, Mueller ER, Kraus SR, Varner E -- 2008
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5-year continence rates, satisfaction and adverse events of burch urethropexy and fascial sling surgery for urinary incontinence. Brubaker L., Richter HE., Norton PA., Albo M., Zyczynski HM., Chai TC., Zimmern P., Kraus S., Sirls L., Kusek JW., Stoddard A., Tennstedt S., Gormley EA. Department of Obstetrics and Gynecology, Loyola University Chicago, Stritch School of Medicine, Chicago, Illinois 60153, USA. L.Brubaker@lumc.edu 2012
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Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 Burch
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2 PVS, fascial
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Design Details
Question... Follow Up Answer Follow-up Answer
Trial Name SISTEr
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Country US
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Quality of life
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Sexual function
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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Intrinsic sphincter deficiency
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Recurrent incontinence after surgery
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Mixed incontinence
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Concomitant prolapse surgery
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RCT Comparison Category Pubovaginal sling vs. Other
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Multicenter Yes
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Institution Type Academic hospital
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Number of surgeons performing procedures Not reported
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Surgeons' Training Urogynecology
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Urology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) A (good)
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Study Sponsor/Funding Government
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Baseline Characteristics
Question Burch PVS, fascial Burch Fascial PVS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 329 326
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Mean Age 52.2 51.6
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Post-Op Follow-Up Interval (Maximum) 24 mo 24 mo
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Results & Comparisons


Results Data
P-Value
Outcome: Overall treatment success      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 329 326 0.01
Percentage 38 47
P-Value
Outcome: Stress-specific success      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 329 326 <0.001
Percentage 49 66
P-Value P-Value
Outcome: satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

Percentage 78 86 0.02


5 years

N Enrolled 172 179 0.04
Percentage 73 83
Outcome: Return to normal voiding at discharge      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


0 weeks

Percentage 58 44
N Analyzed 329 326
Outcome: Return to normal voiding at 6wk      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


6 weeks

Percentage 97 86
N Analyzed 329 326
Outcome: Voiding dysfunction      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


6 weeks

Percentage 2 14
N Analyzed 329 326
P-Value
Outcome: Percent failed stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 <0.001
Percentage 29 13
P-Value
Outcome: Percent failed pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 0.67
Percentage 15 14
P-Value
Outcome: Percent undergoing repeat surgical therapy      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 <0.001
Percentage 11 2
P-Value
Outcome: Composite long-term success measure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.002
Percentage 24.1 30.8
P-Value
Outcome: Subj cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.02
Counts 71 94
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.26
Counts 81 91
P-Value
Outcome: Never surgically retreated by 5 yrs      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 p<0.0001
Percentage 88 98
Outcome: Treated for de novo UUI between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 7 3
Outcome: Treated for persistent UUI between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 29 33
Outcome: Treated for prolapse between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 5 1
Outcome: Treated for voiding dysfunction between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 1 7
P-Value P-Value
Outcome: IIQ improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Analyzed 329 326 0.52
Mean -136.1 -130.3
Standard Deviation 112.1 107.7


5 years

N Analyzed 174 183 0.83
Mean 43.1 44.8
Standard Deviation 68.2 79.6
P-Value
Outcome: Lower urinary tract symptom distress      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Analyzed 174 183 0.05
Mean 50.2 40.2
Standard Deviation 50.9 45.8


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Burch
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2 Fascial PVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Pubovaginal (bladder neck)
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Adverse Event Ascertainment Active
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Was the Clavien-Dindo Classification of Surgical Complications system used? Yes
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Was a data safety monitoring board used? Yes
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Results & Comparisons


Results Data
P-Value
Outcome: Overall treatment success      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 329 326 0.01
Percentage 38 47
P-Value
Outcome: Stress-specific success      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 329 326 <0.001
Percentage 49 66
P-Value P-Value
Outcome: satisfaction      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

Percentage 78 86 0.02


5 years

N Enrolled 172 179 0.04
Percentage 73 83
Outcome: Return to normal voiding at discharge      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


0 weeks

Percentage 58 44
N Analyzed 329 326
Outcome: Return to normal voiding at 6wk      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


6 weeks

Percentage 97 86
N Analyzed 329 326
Outcome: Voiding dysfunction      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


6 weeks

Percentage 2 14
N Analyzed 329 326
P-Value
Outcome: Percent failed stress test      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 <0.001
Percentage 29 13
P-Value
Outcome: Percent failed pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 0.67
Percentage 15 14
P-Value
Outcome: Percent undergoing repeat surgical therapy      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Enrolled 255 265 <0.001
Percentage 11 2
P-Value
Outcome: Composite long-term success measure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.002
Percentage 24.1 30.8
P-Value
Outcome: Subj cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.02
Counts 71 94
P-Value
Outcome: Cure      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 0.26
Counts 81 91
P-Value
Outcome: Never surgically retreated by 5 yrs      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Enrolled 174 183 p<0.0001
Percentage 88 98
Outcome: Treated for de novo UUI between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 7 3
Outcome: Treated for persistent UUI between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 29 33
Outcome: Treated for prolapse between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 5 1
Outcome: Treated for voiding dysfunction between 2.5-5 yrs out      Population: All Participants
Time Point Measure Burch PVS, fascial Burch Fascial PVS


5 years

N Enrolled 174 183
Counts 1 7
P-Value P-Value
Outcome: IIQ improvement      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure Burch vs. PVS, fascial


24 months

N Analyzed 329 326 0.52
Mean -136.1 -130.3
Standard Deviation 112.1 107.7


5 years

N Analyzed 174 183 0.83
Mean 43.1 44.8
Standard Deviation 68.2 79.6
P-Value
Outcome: Lower urinary tract symptom distress      Population: All Participants Between-Arm Comparisons
Time Point Measure Burch PVS, fascial Burch Fascial PVS Comparison Measure ERROR vs. ERROR


5 years

N Analyzed 174 183 0.05
Mean 50.2 40.2
Standard Deviation 50.9 45.8

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
Burch Organ injury in OR (urethra, bladder, bowel) Ureteral injury ND ND Yes Dindo Grade 3-5 2 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 0 326
Total
Burch Fistula Ureterovaginal fistula ND ND Yes Dindo Grade 3-5 1 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 0 326
Total
Burch Organ injury in OR (urethra, bladder, bowel) Vaginotomy ND ND Yes Dindo Grade 3-5 1 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 0 326
Total
Burch Organ injury in OR (urethra, bladder, bowel) Cystotomy ND ND Yes Dindo Grade 3-5 10 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 2 326
Total
Burch Suture erosion Suture erosion into bladder ND ND Yes Dindo Grade 3-5 1 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 0 326
Total
Burch Infection, UTI Recurrent cystitis leading to dx cysto ND ND Yes Dindo Grade 3-5 5 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 6 326
Total
Burch Infection, UTI Pyelonephritis ND ND Yes Dindo Grade 3-5 1 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Catheter complication Catheter complication - clot requiring cystoscopy ND ND Yes Dindo Grade 3-5 1 329 ND NS
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Retention requiring surgery Voiding dysfunction leading to surgical revision ND ND Yes Dindo Grade 3-5 0 329 ND ND
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Fascial PVS ND ND Yes Dindo Grade 3-5 20 326
Total
Burch Pain, unspecified area (new or different after surgery) Pelvic pain ND ND Yes Dindo Grade 3-5 0 329 ND 0.25
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Fascial PVS ND ND Yes Dindo Grade 3-5 2 326
Total
Burch Bleeding Bleeding ND ND Yes Dindo Grade 3-5 3 329 ND 0.62
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Wound complication Wound complication requiring surgical intervention: incisional hernia, seroma or hematoma, infection ND ND Yes Dindo Grade 3-5 13 329 ND 0.83
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Fascial PVS ND ND Yes Dindo Grade 3-5 11 326
Total
Burch Gastrointestinal rectal injury (1) and constipation requiring surgical disimpaction (1) ND ND Yes Dindo Grade 3-5 1 329 ND 1.0
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Respiratory distress Requiring intubation ND ND Yes Dindo Grade 3-5 0 329 ND 0.50
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Laryngospasm Requiring intubation ND ND Yes Dindo Grade 3-5 0 329 ND 0.50
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Fascial PVS ND ND Yes Dindo Grade 3-5 1 326
Total
Burch Infection, UTI Cystitis ND ND No Dindo Grade 1-2 202 329 ND <0.001
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Fascial PVS ND ND No Dindo Grade 1-2 299 326
Total
Burch Infection, UTI Pyelonephritis ND ND No Dindo Grade 1-2 1 329 ND <0.001
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Fascial PVS ND ND No Dindo Grade 1-2 6 326
Total
Burch DVT ND ND No Dindo Grade 1-2 0 329 ND 0.29
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Fascial PVS ND ND No Dindo Grade 1-2 1 326
Total
Burch Bleeding Bleeding ND ND No Dindo Grade 1-2 5 329 ND 0.29
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Fascial PVS ND ND No Dindo Grade 1-2 8 326
Total
Burch Wound complication sling exposure (2), incisional hernia (3), superficial separation (15), seroma (24), infection (52), granulation tissue (44) ND ND No Dindo Grade 1-2 69 329 ND 0.69
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Fascial PVS ND ND No Dindo Grade 1-2 71 326
Total
Burch Gastrointestinal Ileus (7), Other (anal fisures, constipation, n/v, abd pain, etc) (8) ND ND No Dindo Grade 1-2 7 329 ND 0.80
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Fascial PVS ND ND No Dindo Grade 1-2 8 326
Total
Burch Pulmonary Atelectasis (10), pneumonia (3), pulm edema (2), other (4) ND ND No Dindo Grade 1-2 10 329 ND 1.0
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Fascial PVS ND ND No Dindo Grade 1-2 9 326
Total
Burch Neurologic Sciatica (2), numbness/weakness (7), vertigo (2) ND ND No Dindo Grade 1-2 6 329 ND 1.0
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Fascial PVS ND ND No Dindo Grade 1-2 5 326
Total
Burch Cardiovascular Bradycardia (1), ROMI (1) ND ND No Dindo Grade 1-2 0 329 ND 0.25
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Fascial PVS ND ND No Dindo Grade 1-2 2 326
Total
Burch Constitutional Fever unknown origin (2), hypokalemia (1) ND ND No Dindo Grade 1-2 3 329 ND .025
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Fascial PVS ND ND No Dindo Grade 1-2 0 326
Total
Burch Allergic/hives ND ND No Dindo Grade 1-2 0 329 ND 0.25
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Fascial PVS ND ND No Dindo Grade 1-2 2 326
Total
Burch Dermatologic Rash, erythema ND ND No Dindo Grade 1-2 2 329 ND 0.45
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Fascial PVS ND ND No Dindo Grade 1-2 4 326
Total
Burch Postop UUI (total) total treated, not de novo 24 mo After discharge No Dindo Grade 1-2 65 329 ND 0.04
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Fascial PVS 24 mo After discharge No Dindo Grade 1-2 87 326
Total
Burch Postop UUI (de novo) de novo treated, not total 24 mo After discharge No Dindo Grade 1-2 11 329 ND NS
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Fascial PVS 24 mo After discharge No Dindo Grade 1-2 11 326
Total