Clinical trial · Interventional
Application of Tachosil During Lymphadenectomy
Does Intraoperative Application of TachoSil Reduce the Number of Lymphocele After Pelvic Lymphadenectomy?
- 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)
The prevention of lymphoceles was assessed using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland; NCT Number ICMJE NCT01192022; Other Study ID Numbers ICMJE TC-2402-040-SP; U1111-1130-9121 Registry Identifier: WHO) on 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL). Methods: Each patient was simultaneously randomized in two groups: as a control (side without Tachosil applied) and study group (side with Tachosil applied). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment.
Conditions
Conditions (3)
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 |
| Lymphocele | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACHOSIL GROUP | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TACHOSIL GROUP
- description
- Surgical procedures were performed by four doctors with extensive experience in oncological gynecology. A TachoSil® absorbable patch of 4.8x4.8 cm was attached, once, intraoperatively to one side of the obturator fossa (study group). Specific drainage of the retroperitoneum was performed.
- interventionNames
- Biological: TACHOSIL GROUP
- type
- NO_INTERVENTION
- label
- GROUP WITHOUT TACHOSIL
- description
- The same patient constituted also control group, because no TachoSil® absorbable patche was used on the second side of lymphadenectomy. Specific drainage of the retroperitoneum was performed.
Primary outcomes (1)
- measure
- The incidence and volume of lymphocele.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * cervical cancer (FIGO IA1, IA2, IB1, IB2) * endometrial cancer (FIGO IA, IB, II) * age between 18 and 70 years * signed a written informed consent Exclusion Criteria: * lymph edema * disease of the lymphatic system * a known disease of the immune system
References
Publications (2)
- RESULTTinelli A, Giorda G, Manca C, Pellegrino M, Prudenzano R, Guido M, Dell'Edera D, Malvasi A. Prevention of lymphocele in female pelvic lymphadenectomy by a collagen patch coated with the human coagulation factors: a pilot study. J Surg Oncol. 2012 Jun 15;105(8):835-40. doi: 10.1002/jso.22110. Epub 2011 Oct 10. PMID 21987409
- RESULTTinelli A, Mynbaev OA, Tsin DA, Giorda G, Malvasi A, Guido M, Nezhat FR. Lymphocele prevention after pelvic laparoscopic lymphadenectomy by a collagen patch coated with human coagulation factors: a matched case-control study. Int J Gynecol Cancer. 2013 Jun;23(5):956-63. doi: 10.1097/IGC.0b013e31828eeea4. PMID 23574881