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

NCT ID: NCT02629510

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-08-31

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tachosil

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

Group Type: EXPERIMENTAL

Tachosil

Intervention Type: DRUG

No Tachosil

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tachosil

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeong-Yeol Park

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Kim J, Park JY. Hemostatic Efficacy of TachoSil in Loop Electrosurgical Excisional Procedure: A Prospective Randomized Controlled Study. J Low Genit Tract Dis. 2025 Apr 1;29(2):123-130. doi: 10.1097/LGT.0000000000000867. Epub 2025 Jan 22.

Reference Type: DERIVED

PMID: 39842025 (View on PubMed)

Other Identifiers

TACO_1234

Identifier Type: -

Identifier Source: org_study_id