Cervical Cancer Clinical Trial
Official title:
A Randomized Controlled Trial Evaluating the Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP) in Patients With Cervical Intraepithelial Neoplasia or Cervical Cancer
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
A loop electrosurgical excisional procedure(LEEP) is a medical technology which is very
commonly used in order to treat cervical intraepithelial neoplasia and cervical cancer stage
FIGO IA1, as well as diagnose the disease. Though a loop electrosurgical excisional
procedure of cervix is an effective and safe procedure, it may cause discomfort due to
bleeding after surgery, and there are many cases in which additional treatment shall be
implemented in order to control hemorrhage.
Up to now, a number of investigators have made efforts to reduce frequency of bleeding and
additional hemostasis treatment after loop electrosurgical excisional procedure of cervix.
Among the methods that have been studied so far, there are methods in which albothyl
solution, Monsel's solution, Tranexamic acid, Amino-Cerve, or Fibrin glue are applied to the
surgical margin of cervix, of which the bleeding has been stopped by using the
electrocautery method. However, none of them has been recognized to be effective in reducing
the frequency of bleeding and additional hemostasis treatment after loop electrosurgical
excisional procedure of cervix. Accordingly, it is required to carry out researches to find
new methods.
Tachosil, as an absorbable hemostatic surgical patch, is composed of collagen matrix on
which coagulation factor, human fibirinogen and human thrombin are coated. It has been
proved that Tachosil is an effective and safe styptic in a digestive, hapatobiliary,
pulmonary, renal surgery. Unlike the existing styptic, the surgical patch Tachosil has
strong adhesion to bleeding points, plugging up bleeding holes, so that it is expected to
have a great effect on prevention of bleeding on surgical margin of cervix after loop
electrosurgical excisional procedure of cervix.
This study is aimed at evaluating if the application of Tachosil is effective for prevention
of bleeding after a loop electrosurgical excisional procedure of cervix.
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