Tachosil for the Prevention of Symptomatic Lymph Cysts

Summary

This is a randomized trial of 140 women with endometrial or cervical cancer undergoing removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to the pelvic side wall after tissue removal is tested against no such intervention after tissue removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade \>2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. The study's hypothesis is that the application of tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.

Timeline

Start

2011-11

Primary completion

2016-01

Completion

2016-01

Publications

• Background O'Hanlan KA, Pinto RA, O'Holleran M. Total laparoscopic hysterectomy with and without lymph node dissection for uterine neoplasia. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):449-52. doi: 10.1016/j.jmig.2007.02.012.
• Background Marchiole P, Benchaib M, Buenerd A, Lazlo E, Dargent D, Mathevet P. Oncological safety of laparoscopic-assisted vaginal radical trachelectomy (LARVT or Dargent's operation): a comparative study with laparoscopic-assisted vaginal radical hysterectomy (LARVH). Gynecol Oncol. 2007 Jul;106(1):132-41. doi: 10.1016/j.ygyno.2007.03.009. Epub 2007 May 9.
• Background Xu H, Chen Y, Li Y, Zhang Q, Wang D, Liang Z. Complications of laparoscopic radical hysterectomy and lymphadenectomy for invasive cervical cancer: experience based on 317 procedures. Surg Endosc. 2007 Jun;21(6):960-4. doi: 10.1007/s00464-006-9129-0. Epub 2007 Feb 8.
• Background Simonato A, Varca V, Esposito M, Venzano F, Carmignani G. The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study. J Urol. 2009 Nov;182(5):2285-90. doi: 10.1016/j.juro.2009.07.033. Epub 2009 Sep 16.
• Background Panici PB, Plotti F, Zullo MA, Muzii L, Manci N, Palaia I, Ruggiero A, Angioli R. Pelvic lymphadenectomy for cervical carcinoma: laparotomy extraperitoneal, transperitoneal or laparoscopic approach? A randomized study. Gynecol Oncol. 2006 Dec;103(3):859-64. doi: 10.1016/j.ygyno.2006.05.025. Epub 2006 Jun 27.
• Background Frilling A, Stavrou GA, Mischinger HJ, de Hemptinne B, Rokkjaer M, Klempnauer J, Thorne A, Gloor B, Beckebaum S, Ghaffar MF, Broelsch CE. Effectiveness of a new carrier-bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: a randomised prospective trial. Langenbecks Arch Surg. 2005 Apr;390(2):114-20. doi: 10.1007/s00423-005-0543-x. Epub 2005 Feb 19.
• Background Anegg U, Lindenmann J, Matzi V, Smolle J, Maier A, Smolle-Juttner F. Efficiency of fleece-bound sealing (TachoSil) of air leaks in lung surgery: a prospective randomised trial. Eur J Cardiothorac Surg. 2007 Feb;31(2):198-202. doi: 10.1016/j.ejcts.2006.11.033. Epub 2006 Dec 21.
• Background Siemer S, Lahme S, Altziebler S, Machtens S, Strohmaier W, Wechsel HW, Goebell P, Schmeller N, Oberneder R, Stolzenburg JU, Becker H, Luftenegger W, Tetens V, Van Poppel H. Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study. Eur Urol. 2007 Oct;52(4):1156-63. doi: 10.1016/j.eururo.2007.04.027. Epub 2007 Apr 18.
• Background Grimm C, Polterauer S, Helmy S, Cibula D, Zikan M, Reinthaller A, Tempfer C. A collagen-fibrin patch (Tachosil(R)) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial. BMC Cancer. 2014 Aug 30;14:635. doi: 10.1186/1471-2407-14-635.
• Results Grimm C, Polterauer S, Helmy-Bader S, Zikan M, Cibula D, Heitz F, Harter P, Giese A, Reinthaller A, Tempfer C. A collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: A randomized clinical trial. Gynecol Oncol. 2018 Apr;149(1):140-145. doi: 10.1016/j.ygyno.2018.01.012. Epub 2018 Feb 12.

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