کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6145557 1594913 2014 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery
ترجمه فارسی عنوان
اثربخشی چشمک زدن: برش های سوزنی شام در یک کارآزمایی تصادفی شده از یک سینه مرمریک رتروپوبیکی در زنان تحت عمل جراحی پرولاپس واژن
کلمات کلیدی
پرولاپس اندام لگن برش شام بی اختیاری ادرار استرس، محاکمه جراحی،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
چکیده انگلیسی

ObjectiveThis planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception.Study DesignSham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed.ResultsPrior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42).ConclusionSham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: American Journal of Obstetrics and Gynecology - Volume 211, Issue 5, November 2014, Pages 554.e1-554.e7
نویسندگان
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