Kastl Konrad G, Betz Christian S, Siedek Vanessa, Leunig Andreas
Department of Otorhinolaryngology, University Hospital Ulm, University of Ulm, Germany.
Eur Arch Otorhinolaryngol. 2009 Aug;266(8):1239-43. doi: 10.1007/s00405-008-0881-8. Epub 2008 Dec 12.
The aim of this study is to evaluate the haemostatic effect of carboxy-methylated cellulose (CMC) nasal packing following functional endoscopic sinus surgery (FESS). The design includes an investigator-initiated, randomized, single-blinded, controlled, prospective clinical study. A bilateral FESS procedure was performed on 41 patients. At the end of the operation, one side was randomly filled with CMC nasal packing, the other side remained without packing. The patients were blinded to the side of nasal packing and were postoperatively examined on the 1st day, after 2 and 4 weeks and the extent of the postoperative bleeding was quantified with a clinical grading system. Even though there were slightly more postoperative bleedings reported for the non-packed sides as compared to the CMC-packed sides, these differences were at no point statistically significant within the monitored postoperative period of 4 weeks. In the examined collective, the CMC packing investigated did not statistically prove to have an effect on bleeding control in this study design.
本研究旨在评估功能性鼻内镜鼻窦手术(FESS)后羧甲基纤维素(CMC)鼻腔填塞的止血效果。该设计包括一项研究者发起的、随机、单盲、对照、前瞻性临床研究。对41例患者进行了双侧FESS手术。手术结束时,一侧随机填入CMC鼻腔填塞物,另一侧不进行填塞。患者对鼻腔填塞侧不知情,并在术后第1天、2周和4周后接受检查,术后出血程度采用临床分级系统进行量化。尽管与使用CMC填塞的一侧相比,未填塞侧报告的术后出血略多,但在4周的监测术后期间,这些差异在任何时候都没有统计学意义。在本研究设计中,所研究的CMC填塞物在统计学上并未证明对出血控制有效果。