Clinical trial NCT02629510: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 268
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Bleeding period after surgery in days
timeFrame: two weeks
Secondary outcomes:
measure: Amount of bleeding after surgery
timeFrame: two weeks
measure: Infection frequency at external genitals, vagina and cervix after surgery
timeFrame: two weeks
measure: Change in life quality after surgery
timeFrame: 4 weeks prior to, during the period between 14 and 21 days after, and 6 weeks after, respectively
measure: Amount of vaginal discharge
timeFrame: two weeks
measure: Frequency of additional treatment due to bleeding after surgery
timeFrame: two weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
References: