Clinical trial · Interventional
Tachosil for the Prevention of Symptomatic Lymph Cysts
A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Symptomatic Lymphoceles After Pelvic Lymphadenectomy in Women With Gynecologic Malignancies: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tachosil fibrin patch | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- application of Tachosil fibrin patches
- description
- 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.
- interventionNames
- Drug: Tachosil fibrin patch
- type
- NO_INTERVENTION
- label
- Control group
- description
- In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.
Primary outcomes (1)
- measure
- symptomatic lymph cysts
- timeFrame
- 4 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing open or laparoscopic surgery for cervical or endometrial cancer * Age between 18 and 70 yrs * Informed consent Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDO'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
- BACKGROUNDMarchiole 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
- BACKGROUNDXu 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
- BACKGROUNDSimonato 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
- BACKGROUNDPanici 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
- BACKGROUNDFrilling 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.