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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
2204 (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
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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 ... 4 university, 13 central, and 21 local
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No. of Surgeons Performing the Procedures Unclear/Not reported
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Surgeons' Training Urogynecology
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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) Data was obtained via a national registry.
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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 >200cc; 18 cases no intervention; 5 treated with pressure; 1 treated with Caprilon+transfusion; 1 treated with laparotomy; 2 treated with pressure+Caprilon 2 months in-hospital no yes 27
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) bladder perforation; one fistula resulted from unrecognized injury. 2 months In-hospital no yes 56
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) urethral injury 2 months In-hospital no yes 1
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Retropubic synthetic Transfusion post-op EBL 2510cc; 3 retropubic hematomas, one hematoma "outside retropubic space" 2 months In-hospital no yes 5
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) obturator nerve injury 2 months In-hospital no yes 1
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Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) epigastric vessel injury 2 months In-hospital no yes 1
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Retropubic synthetic complete postoperative urinary retention defined as inability to void POD2; 1 case required reoperation 3 months In-hospital no yes 34
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Retropubic synthetic voiding difficulty defined as PVR>100; 2 cases required reoperation 4 months In-hospital no yes 111
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Retropubic synthetic Retention requiring surgery Combined from above 2 categories 4 months in hospital and after discharge no yes 4
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Retropubic synthetic Infection, surgical site/wound ABDOMINAL: 7 uncomplicated, one cellulitis, 4 abscesses (all drained) not specified in-hospital and after discharge no yes 12
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Retropubic synthetic Infection, UTI 2 months after discharge no yes 59
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Retropubic synthetic Return to OR exact number not explicitly stated; 3 bleeding, 7 injury, 3 voiding dysfx, 4 infection 4 months In hospital and after discharge no yes 17
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Retropubic synthetic DVT 2 months in-hospital no yes 1
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Retropubic synthetic defect healing the vaginal incision defect healing the vaginal incision 2 months after discharge no yes 10
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Retropubic synthetic Pain, other (new or different after surgery) "pain in gluteal muscle or thigh"; 1 case requires transection 2/2 obturator compression 2 months after discharge no yes 3
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