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

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center

Criteria

Inclusion Criteria

• Over 20 years old

• Patients who have to undergo a loop electrosurgical excisional procedure as they have been diagnosed with cervical intraepithelial neoplasia or cervical cancer, including patients whose symptoms are suspicious for such diseases.

• Patients who are able to sign a informed consent, and who have signed.

Exclusion Criteria

• Patients who have experienced a treatment due to diagnosis of cervical intraepithelial neoplasia or cervical cancer

• Patients who have a disease of bleeding tendancy, or patients who have taking drugs.

• Patients with abnormal uterine bleeding or vaginal bleeding.

• Patients with active medical disease

• Patients with uncontrollable medicall disease

• Patients who are pregnant or breastfeeding

• Patients who can not participate in the clinical study due to legal restrictions