This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

  • Home
  • Published Projects
  • Registries
Advanced Search

Study Preview



Study Title and Description

Osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery: report from single largest prospective series and literature review.



Key Questions Addressed
2 Sling Adverse Events
  • Comments Comments (
    0
    ) |
  • Post/View

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery: report from single largest prospective series and literature review.
Author Frederick RW., Carey JM., Leach GE.
Country Tower Urology Institute for Continence, Los Angeles, California 90048, USA.
Year 2004
Numbers Pubmed ID: 15491696
1237 (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 Cadaveric transvaginal sling with bone anchor fixation
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective Cohort (all received same sling)
  • Comments Comments (
    0
    ) |
Study Country US
  • Comments Comments (
    0
    ) |
Sling Category ... Other ... Cadaveric transvaginal sling with bone anchor fixation
  • Comments Comments (
    0
    ) |
Multicenter? No
  • Comments Comments (
    0
    ) |
Institution Type Community hospital
  • Comments Comments (
    0
    ) |
No. of Surgeons Performing the Procedures Unclear/Not reported
  • Comments Comments (
    0
    ) |
Surgeons' Training Urology
  • Comments Comments (
    0
    ) |
Residents or Fellows Performing the Surgery? Unclear/Not reported
  • Comments Comments (
    0
    ) |
Adverse Event Ascertainment Active
  • Comments Comments (
    0
    ) |
Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
  • Comments Comments (
    0
    ) |
Was a data safety monitoring board used? No / Not reported
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding Not reported
  • Comments Comments (
    0
    ) |
Comments (overall study) This study is a retrospective cohort and a review of the literature specifically looking at reported cases of osteitis and osteomielitis following transvaginal slings with bone anchor fixation. They used solvent dehydrated nonfrozen cadaveric fascia lata.They had 485 patients in their database. 440 had the minimum accepted follow up of 3 months. They performed slings on 127 patients, and sling plus cadaveric prolapse repair with sling in 313 patients. The report only makes reference to osseus complications. They also performed a literature review from 1995 to 2003, and they reported 1 case of osteomyelitis. I did not include the results from the literature review in the AEs report.
  • Comments Comments (
    0
    ) |




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
Cadaveric transvaginal sling with bone anchor fixation Pain, other (new or different after surgery) Pelvic pain, new onset 12 months After discharge No 6 440
  • Comments Comments (
    0
    ) |
Total
Cadaveric transvaginal sling with bone anchor fixation Pubis Osteitis Clinical, radiographic criteria outlined in Table III 12 months After discharge Yes 2 440
  • Comments Comments (
    0
    ) |
Total