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Study Title and Description

A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure.
Author Kuuva N., Nilsson CG.
Country Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, FIN-00029 HUS, Helsinki, Finland. nina.kuuva@hus.fi
Year 2002
Numbers Pubmed ID: 11942891
7754 (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 Retropubic synthetic TVT- standard fashion
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Retrospective Cohort (all received same sling)
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Study Country ... Other ... finland
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Sling Category Retropubic synthetic
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Multicenter? Yes
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Institution Type ... Other ... 38 hospitals:4 university, 13 central and 21 local hospital
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No. of Surgeons Performing the Procedures ... Other ...
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Surgeons' Training Urogynecology
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Other ... general gynecology
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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 Academia
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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
Retropubic synthetic blood loss over 200 ml 18 - no intervention 1- blood transfusion 1- laparotomy and sling removal peri-operative serious was defined as needing laparotomy or potentially life threatening 27 (1.9%) 1455 1.2-2.7 95%CI
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation 1- tvt removed due to proximity to ureter meatus, 5- tape removed 2hours-pod#4 after surgery peri-operative no 56(3.8%) 1455 2.9-5.0 95%CI
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Retropubic synthetic blood vessle injury epigastric vessel perioperative no 1(0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic nerve injury obturator nerve perioperative no 1(0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic hematoma vaginal perioperative no 1(0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) urethra perioperative no 1(0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic complete urinary retention not requiring surgery - 1 sling cut (3m) post operative 3h-3 months 34(2.3%) 1455 1.6-3.3 95%CI
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Retropubic synthetic voiding difficulty observation 2- sling cut 2d-4 months 111(7.6%) 1455 6.3-9.2 95%CI
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Retropubic synthetic retropubic hematoma 3 - needed blood transfusion
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Total 27(1.9%) 1455 1.2-2.7 95%CI
Retropubic synthetic hematoma outside the retropubic area 1 needed blood transfusion 7 (0.5%) 1455 0.2-1.0 95%CI
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Retropubic synthetic Infection, surgical site/wound abdominal site. 4 abcesses surgically drained 12(0.8%) 1455 0.4-1.4 95%CI
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Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue defect healing of the vaginal incision; 4 resutured, 2-partial removal of tape, 3- no intervention 10 (0.7%) 1455 0.3-1.3 95%CI
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Retropubic synthetic Infection, UTI 59 (4.1%) 1455 3.1-5.2 95%CI
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Retropubic synthetic de novo urgency 11 (0.8%) 1455 0.4-1.4 95%CI
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) vesicovaginal fistula 1 (0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic Pain, unspecified area (new or different after surgery) gluteal muscle and thigh 3 (0.2%) 1455 0.0-0.6 95%CI
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Retropubic synthetic DVT 1(0.1%) 1455 0.0-0.4 95%CI
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Retropubic synthetic seroma 1(0.1%) 1455 0.0-0.4 95%CI
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