drugset / Trial / NCT02629510
The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP)
RandomizedParallel-groupSingle-blindPrevention
Summary
This study is aimed at identifying the efficacy of Tachosil® for prevention of hemorrhage in patients with cervical intraepithelial neoplasia or cervical cancer after undergoing a loop electrosurgical excisional procedure (LEEP). 1. Primary endpoint: Bleeding period within two weeks after surgery Frequency of additional treatment due to bleeding within two weeks after surgery 2. Secondary endpoint: Amount of bleeding within two weeks after surgery Infection frequency at external genitals, vagina and cervix within two weeks after surgery Change in life quality after surgery
Timeline
- Start
- 2015-01
- Primary completion
- 2017-08
- Completion
- 2017-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TachoSil | Other / unclassified | — | Topical |