丹麦2009年11月开始的脊髓损伤病人试验,目标定的很好:能不能拉大便


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送交者: 羽矢 于 2011-03-03, 00:47:48:

回答: 谁知道他们定出的clinical significance是什麽吗? 由 cornbug 于 2011-03-03, 00:11:40:

http://clinicaltrials.gov/ct2/show/NCT01274312
Primary Outcome Measures:
* Colorectal emptying [ time frame: 18 month postoperative for last included patient ] [ designated as safety issue: yes ]
Colorectal emptying at defecation after somato-autonomic reflex stimulation is mesaured using colorectal scintigraphy pre- and 18 month postoperatively

而且,成功、失败都找好了退路。不像Beaumont,一看效果不好就重新定义success:

Before the widespread use of somato-sensory reflex arch we find it of utmost importance that well designed studies with validated or even objective endpoints are performed. Results of such studies will have an international impact in either defining indications for a completely new treatment principle or, otherwise, in preventing the widespread use of an ineffective treatment.




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