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Study Title and Description

Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure.



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 Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure.
Author Persson J., Teleman P., Etén-Bergquist C., Wølner-Hanssen P.
Country Department of Obstetrics and Gynecology, University Hospital Lund, Lund, Sweden. jan.persson@gyn.lu.se
Year 2002
Numbers Pubmed ID: 12421176
2894 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 TVT TVT: short longitudinal incision at midurethra, graft placed around urethra with disposable needles. Performed under local anesthesia. 50-75mcg fentanyl IV and 30-100 mg propofol at onset and additional 25-50mcg fentanyl and 25-50mg propofol at graft placement.
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2 Burch, laparoscopic Laparoscopic burch: GETA, space of retzius dissected, vaginal fascia lifted against Coopers ligament w 2 goretex sutures, placed 2cm lateral to the urethra, and 2cm distal to the bladder neck.
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Design Details
Question... Follow Up Answer Follow-up Answer
Country Sweden
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Outcome Categories Reported Objective SUI
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Subjective SUI
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OR outcomes/complications (not "AEs")
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Other (we expect this to rarely or never be chosen) ... cost
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Population (reason for surgery etc.) Symptomatic SUI
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RCT Comparison Category Sling vs. Burch
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Multicenter No
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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 ... Other ... Dept of Ob Gyn
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) B (fair)
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Study Sponsor/Funding ... Other ... unclear
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Baseline Characteristics
Question TVT Burch, laparoscopic Retropubic synthetic L/S Burch Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 38 33 71
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Mean Age 51 median 48 median
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Post-Op Follow-Up Interval (Maximum) 1yr 1yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-pad test cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 33 27
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- pad test improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 2 4
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- pad test unimproved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 2 0
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 21 16
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective- much improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 10 14
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective-little improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 3 1
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective- unimproved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts
Standard Deviation 3 0
---


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in OR-total time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 96.3 128
Standard Deviation
<.0001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR-anesthesia time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Analyzed 38 32
Mean 77.3 117.6
Standard Deviation
<.0001


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR-surgical time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 44.9 59.9
Standard Deviation
<.0001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Costs- Avg total cost of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 1342.8 1273.4
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Costs- Avg total cost of procedure including reopertion      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Analyzed 38 32
Mean
Standard Deviation 1462.6 1314.5
<.001


0 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic TVT
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2 L/S Burch GETA, space of retzius dissected, vaginal fascia lifted against Coopers ligament w 2 goretex sutures, placed 2cm lateral to the urethra, and 2cm distal to the bladder neck
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country Sweden
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Sling Category Retropubic synthetic
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Multicenter? No
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Institution Type Academic hospital
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Other ... Department of ObGyn
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training ... Other ... Department of ObGyn
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Unclear/Not reported
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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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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective-pad test cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 33 27
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- pad test improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 2 4
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective- pad test unimproved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 2 0
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective cure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 21 16
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective- much improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts 10 14
Standard Deviation
---


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective-little improved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Enrolled
Counts
Standard Deviation


1 years

N Enrolled 37 31
Counts 3 1
Standard Deviation
---
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI subjective- unimproved      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Enrolled 37 31
Counts
Standard Deviation 3 0
---


0 years

N Enrolled
Counts
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Time in OR-total time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 96.3 128
Standard Deviation
<.0001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR-anesthesia time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Analyzed 38 32
Mean 77.3 117.6
Standard Deviation
<.0001


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Time in OR-surgical time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 44.9 59.9
Standard Deviation
<.0001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Costs- Avg total cost of procedure      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


0 years

N Analyzed 38 32
Mean 1342.8 1273.4
Standard Deviation
<.001


1 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Costs- Avg total cost of procedure including reopertion      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT Burch, laparoscopic Retropubic synthetic L/S Burch Comparison Measure TVT vs. Burch, laparoscopic


1 years

N Analyzed 38 32
Mean
Standard Deviation 1462.6 1314.5
<.001


0 years

N Analyzed
Mean
Standard Deviation

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
Retropubic synthetic Return to OR all reoperations for SUI 1yr after discharge 3 38
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L/S Burch 1yr after discharge 1 32
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation in hospital 1 38
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L/S Burch
Total
Retropubic synthetic Obstruction requiring reoperation Immediate postop dilation with hegar dilator 1yr in hospital 1 38
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L/S Burch
Total