Borchert Dietmar H, Federlein Matthias, Müller Verena A, Wagenpfeil Stefan, Eisele Robert M
Department of General, Visceral, Vascular and Pediatric Surgery, and Institute of Biometry, Epidemiology and Medical Informatics, Saarland University Hospitals, Kirrberger Straße 100, 66421, Homburg, Saarland, Germany.
Department of General and Visceral Surgery, Sana Hospital Lichtenberg, Sana Hospitals Berlin-Brandenburg, Affiliated Teaching Hospital to the Charité, Fanningerstraße 32, 10365, Berlin, Germany.
Surg Endosc. 2015 Oct;29(10):2928-33. doi: 10.1007/s00464-014-4023-7. Epub 2014 Dec 25.
This investigation uses the comprehensive complication index (CCI) to compare complications after natural orifice transluminal endoscopic surgery (NOTES) procedures.
NOTES procedures are developed to miniaturize surgical trauma. NOTES publications inconsistently report complications. The CCI improves reporting of complications.
The CCI is calculated using complication data from a single center, double blind, randomized controlled trial comparing transvaginal [transvaginal cholecystectomy (TVC), N = 41] and conventional laparoscopic cholecystectomy (CLC, N = 51). Complications are assessed using the classification of surgical complications (CSC). Two different scenarios are applied to the CSC for definition of complications with an emphasis on minor complications. CSC data are fed into the free online CCI-calculator. The CCIs from complication data from other NOTES reports are calculated accordingly and compared to our results.
The CCI allows easy indexing of complications with or without a CSC table. For scenario I, the mean CCI of CLC versus TVC is 3.3 (± 6.3; SD) versus 3.5 (± 6.4; n.s.) and for scenario II it is 7.6 (± 6.4) versus 6.5 (± 7.0; n.s.). The difference of the mean between the two scenarios is highly significant (p < 0.000). The mean CCIs of both groups and scenarios are below the CCI of 8.7 for a grade I CSC complication. Similar calculation of CCIs from other NOTES publications yields mean CCIs below 8.7 for the surgical procedures reported.
The CCI results in a single, easily comparable complication index for surgical procedures whereas the CSC yields tabular results. A significant difference in interpretation occurs with variation in definition of complications. Average CCIs below a value of 10 describe low complication rates. Authors need to describe their definition of complications if using the CSC and the CCI. More emphasis should be given to reporting of minor complications. The use of the CCI for NOTES procedures will enable international comparison.
本研究采用综合并发症指数（CCI）比较经自然腔道内镜手术（NOTES）术后的并发症。
NOTES手术旨在将手术创伤降至最小。NOTES相关文献对并发症的报道并不一致。CCI有助于改善并发症的报告。
使用来自一项单中心、双盲、随机对照试验的并发症数据计算CCI，该试验比较经阴道[经阴道胆囊切除术（TVC），N = 41]和传统腹腔镜胆囊切除术（CLC，N = 51）。采用手术并发症分类（CSC）评估并发症。将两种不同情况应用于CSC以定义并发症，重点关注轻微并发症。将CSC数据输入免费在线CCI计算器。相应计算其他NOTES报告并发症数据的CCI，并与我们的结果进行比较。
无论有无CSC表，CCI都能轻松对并发症进行索引。对于情况I，CLC与TVC的平均CCI分别为3.3（±6.3；标准差）和3.5（±6.4；无显著差异）；对于情况II，分别为7.6（±6.4）和6.5（±7.0；无显著差异）。两种情况之间平均差异非常显著（p < 0.000）。两组和两种情况的平均CCI均低于I级CSC并发症的CCI 8.7。对其他NOTES出版物进行类似的CCI计算，所报告手术的平均CCI低于8.7。
CCI为手术操作产生一个单一、易于比较的并发症指数，而CSC产生表格结果。并发症定义的变化会导致解释上的显著差异。平均CCI低于10表明并发症发生率低。如果使用CSC和CCI，作者需要描述其对并发症的定义。应更加强调轻微并发症的报告。NOTES手术使用CCI将有助于进行国际比较。
