Tachosil for the Prevention of Symptomatic Lymph Cysts

NCT01470677 | Completed Phase 3

• 1 other identifier: TACH-01
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Endometrial Cancer; Cervical Cancer

Keywords

lymph cyst; lymphocele; fibrin; collagen; prevention; cancer

Outcome Measures

Primary Outcomes (1)

• symptomatic lymph cysts

  Primary outcome variable: 2.1. 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.

  4 weeks

Secondary Outcomes (1)

• asymptomatic lymph cysts, intervention rate due to symptomatic lymph cysts

  4 weeks

Study Arms (2)

application of Tachosil fibrin patches

EXPERIMENTAL

A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group.

Drug: Tachosil fibrin patch

Control group

NO INTERVENTION

In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.

Interventions

Tachosil fibrin patch DRUG

A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group. In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.

Also known as: EU registration number: EU/1/04/277/002

application of Tachosil fibrin patches

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing open or laparoscopic surgery for cervical or endometrial cancer
• Age between 18 and 70 yrs
• Informed consent

You may not qualify if:

• Women with previously diagnosed lymph edema
• Known disease of the lymphatic system
• Immunocompromised women such as those with an immunosuppressive medication or a known disease of the immune system

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (2)

Medical University of Vienna

Vienna, A-1090, Austria

Location

Ruhr University Bochum

Bochum, D-44625, Germany

Location

Related Publications (10)

• 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.

  PMID: 17630162 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.

  PMID: 17493666 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.

  PMID: 17287919 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.

  PMID: 19762048 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.

  PMID: 16806442 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.

  PMID: 15723234 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.

  PMID: 17187983 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.

  PMID: 17467884 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.

  PMID: 25175029 BACKGROUND

• 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.

  PMID: 29395308 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms; Lymphocele; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Cysts; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clemens Tempfer, MD

  Ruhr University Bochum, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Clemens Tempfer

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

AU (1); DE (1)