N/A
Completed N=233
Use of Tachosil® for Lymph Sealing During Surgery
Lymph Node Resection
Source: ClinicalTrials.gov NCT01920958 ↗
Enrolled (actual)
233
Serious AEs
3.1%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge — 2.63 percentage of participants
Summary
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge |
2.63 | — |
| SECONDARY Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale |
2.2 | — |
| SECONDARY Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale |
2.3 | — |
| SECONDARY Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale |
2.3 | — |
| SECONDARY Percentage of Participants With at Least One Drainage Inserted |
81.14 | — |
| SECONDARY Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume |
48.65; 57.84 | — |
| SECONDARY Length of Hospital and ICU Stay |
12.2; 2.8 | — |
| SECONDARY Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time |
17.98 | — |
| SECONDARY Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay |
27.19 | — |
| SECONDARY Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU |
8.77 | — |
| SECONDARY Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced |
35.96 | — |
| SECONDARY Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced |
39.04 | — |
| SECONDARY Percentage of Participants With Post-Operative Complications and Adverse Events |
18.42; 13.60 | — |
Eligibility Criteria
Inclusion Criteria
- Stationary patients undergoing lymph node resection.
Exclusion Criteria
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Data sourced from ClinicalTrials.gov (NCT01920958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.