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Study Title and Description

A multi-centre, randomised clinical control trial comparing the retropubic (RP) approach versus the transobturator approach (TO) for tension-free, suburethral sling treatment of urodynamic stress incontinence: the TORP study



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title A multi-centre, randomised clinical control trial comparing the retropubic (RP) approach versus the transobturator approach (TO) for tension-free, suburethral sling treatment of urodynamic stress incontinence: the TORP study
Author Barry C, Lim YN, Muller R, Hitchins S, Corstiaans A, Foote A, Greenland H, Frazer M, Rane A.
Country --
Year 2008
Numbers Pubmed ID: 17634853
2019 (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
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2 Transobturator synthetic Monarc
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name TORP
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Study Country Australia
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Sling Category Retropubic synthetic
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Obturator synthetic
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Multicenter? Yes
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures ... Other ... more than 4
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Surgeons' Training ... Other ... each surgeon had to have completed >20 each of TVT and TOT-Monarc
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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 Industry
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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 Mesh erosion/extrusion/exposure/granulation tissue Sling protrusion <3 mo after discharge ND ND 1 82 ND 0.11
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Transobturator synthetic <3 mo after discharge ND ND 3 58 ND
Total
Retropubic synthetic Infection, UTI <3 mo after discharge No ND 11 82 ND 0.81
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Transobturator synthetic <3 mo after discharge No ND 9 58 ND
Total
Retropubic synthetic Retention requiring surgery for PVR >200mL at 3mo or significant sx of voiding dysfunction 3 mo after discharge Yes ND 3 82 ND 0.88
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Transobturator synthetic 3 mo after discharge Yes ND 1 58 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bladder perforation Intraop In-hospital No ND 7 82 ND <0.05
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Transobturator synthetic Intraop In-hospital No ND 0 58 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Urethral perforation Intraop In-hospital ND ND 0 82 ND 0.42
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Transobturator synthetic Intraop In-hospital ND ND 1 58 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Bowel perforation Intraop In-hospital ND ND 0 82 ND NS
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Transobturator synthetic Intraop In-hostpial ND ND 0 58 ND
Total
Retropubic synthetic Transfusion post-op Major hemorrhage Peri-op In-hospital ND ND 0 82 ND NS
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Transobturator synthetic Peri-op In-hospital ND ND 0 58 ND
Total
Retropubic synthetic Retropubic hematoma Hemorrhage Peri-op In-hospital ND ND 1 82 ND 0.53
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Transobturator synthetic Peri-op In-hopital ND ND 0 58 ND
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Retropubic synthetic Retention requiring catheter Retention of cath >2d 2 d after discharge ND ND 14 82 ND 0.21
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Transobturator synthetic 2 d after discharge ND ND 5 58 ND
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Retropubic synthetic Nerve entrapment Suspected posterior division obturator nerve Intraop In-hospital ND ND 0 82 ND 0.53
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Transobturator synthetic Intraop In-hospital ND ND 1 58
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