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

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Drug: Tachosil

Study type: Interventional

Funder types: Other

Identifiers

NCT02629510

TACO_1234

Details and patient eligibility

About

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

Full 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.

Enrollment: 268 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups

Tachosil

Experimental group

Description:

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

Treatment:

Drug: Tachosil

No Tachosil

No Intervention group

Description:

The group composed of patients whose surgical margin of cervix will NOT be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)