drugset / Trial / NCT02629510

The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP)

NCT02629510

Phase 4 Unknown 268 enrolled Asan Medical Center
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

EvaluationDrugModalityDoseRoute
Subject TachoSil Other / unclassified Topical