From "data mining" to "salami publication"--how (not) to present data.
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Biomedical subjects
Publications and source records attributed to Paul Riss.
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OBJECTIVE: This study was undertaken to analyze bleeding problems with tension-free vaginal tape (TVT) operations in a national registry. STUDY DESIGN: We studied patients for whom increased intraoperative bleeding or reoperation for bleeding/hematoma with TVT operation were reported to the registry. RESULTS: Bleeding problems were reported for 151 of 5578 (2.7%) TVT operations. Increased intraoperative bleeding was reported for 106 (1.9%) and reoperation (or conversion) in 45 (0.8%) patients (both in 5 patients). Increased intraoperative bleeding was managed conservatively in 103 patients (95%). Overall, 45 (0.8%) patients required reintervention for bleeding or hematoma. The reinterventions comprised 34 laparotomies, 4 transvaginal evacuations of hematomas, 3 revisions for bleeding from a suprapubic catheter site, and 2 revisions of the vaginal incision (details unclear in 1 patient). Bleeding was considered arterial in 12% (including 1 external iliac artery injury and 1 obturator artery injury) and venous or unknown in 88%. Of reoperated patients, 39% were reoperated within 24 hours, 20% within 2 to 10 days, and 41% within 11 to 56 days after TVT placement. Overall, 19 patients received blood transfusions (range, 1-10 units). There were no deaths from bleeding complications. CONCLUSION: Bleeding complications were reported with less than 3% of 5578 TVT operations. Most cases of increased intraoperative bleeding were managed conservatively; 0.8% of patients required conversion or reoperation.