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一项前瞻性随机试验:根治性腹股沟/髂淋巴结清扫术后术中应用纤维蛋白胶对术后发病率的影响。

A prospective randomized trial: the influence of intraoperative application of fibrin glue after radical inguinal/iliacal lymph node dissection on postoperative morbidity.

作者信息

Neuss H, Raue W, Koplin G, Schwenk W, Reetz C, Mall J W

机构信息

Department of General, Visceral, Thoracic and Vascular Surgery, Charité, Universitaetsmedizin Berlin, Charité, Campus Mitte, Berlin, Germany.

出版信息

Eur J Surg Oncol. 2009 Aug;35(8):884-9. doi: 10.1016/j.ejso.2008.09.016. Epub 2008 Nov 17.

Abstract

BACKGROUND

Effects of intraoperative application of fibrin glue following combined radical inguinal and iliacal lymph node dissection (RILND) on the amount of postoperative lymphatic secretion are discussed controversially. To detect whether fibrin glue application results in a decreased lymphatic secretion following RILND a randomized patient blinded clinical trial was conducted.

METHOD

Between September 2003 and September 2006 58 patients with stage IV melanoma underwent therapeutic RILND and were randomized into two groups. 29 Patients received 4 cc fibrin glue after RILND whereas 29 patients were only irrigated with saline 0.9 percent. Postoperatively all patients received two inguinal and one iliacal closed suction drain. The main outcome criteria were the duration of drain placement in the wound. Minor criteria were the total amount of secretion and the length of hospital stay.

RESULTS

There was no difference between the treatment and the control group in the duration of drain placement (fibrin group: 4 days (1-27); control group 5 days (1-26); p=0.64). The total amount of fluid was 310 cc (30-6005) in the fibrin group vs. 365 cc (30-3945 cc) in the control group (p=0.9) and the length of hospital stay 10 days (3-41) (group 1) compared to 11 days (3-41) (p=0.99) were not different between both groups either.

CONCLUSION

Intraoperative application of 4 cc fibrin glue does not reduce the length of drain placement, drain output or hospitalisation of patients undergoing RILND with melanoma metastasis to the lymph node basin.

摘要

背景

腹股沟和髂淋巴结联合根治性清扫术(RILND)术中应用纤维蛋白胶对术后淋巴分泌量的影响存在争议。为检测RILND术后应用纤维蛋白胶是否会减少淋巴分泌,进行了一项随机、患者盲法的临床试验。

方法

2003年9月至2006年9月,58例IV期黑色素瘤患者接受了治疗性RILND,并随机分为两组。29例患者在RILND术后接受4毫升纤维蛋白胶,而29例患者仅用0.9%的生理盐水冲洗。术后所有患者均留置两根腹股沟和一根髂部闭式负压引流管。主要观察指标为伤口引流管放置时间。次要指标为分泌物总量和住院时间。

结果

治疗组和对照组在引流管放置时间上无差异(纤维蛋白组:4天(1 - 27天);对照组5天(1 - 26天);p = 0.64)。纤维蛋白组的液体总量为310毫升(30 - 6005毫升),对照组为365毫升(30 - 3945毫升)(p = 0.9),住院时间纤维蛋白组为10天(3 - 41天),对照组为11天(3 - 41天)(p = 0.99),两组之间也无差异。

结论

对于有淋巴结转移的黑色素瘤患者行RILND时,术中应用4毫升纤维蛋白胶并不能缩短引流管放置时间、减少引流量或缩短住院时间。

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