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

Brief Title

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

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

Brief 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
    

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Bleeding period after surgery in days

Secondary Outcome

 Amount of bleeding after surgery

Condition

Cervical Intraepithelial Neoplasia

Intervention

Tachosil

Study Arms / Comparison Groups

 Tachosil

Description:  The group composed of patients whose surgical margin of cervix will be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

268

Start Date

January 2015

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility 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
      

Gender

Female

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT02629510

Organization ID

TACO_1234

Responsible Party

Principal Investigator

Study Sponsor

Asan Medical Center

Study Sponsor

, , 

Verification Date

May 2017