The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP) (TACO)
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|ClinicalTrials.gov Identifier: NCT02629510|
Recruitment Status : Unknown
Verified May 2017 by Jeong-Yeol Park, Asan Medical Center.
Recruitment status was: Active, not recruiting
First Posted : December 14, 2015
Last Update Posted : May 31, 2017
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).
Bleeding period within two weeks after surgery Frequency of additional treatment due to bleeding within two weeks after surgery
- 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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia Cervical Cancer||Drug: Tachosil||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||January 2015|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
The group composed of patients whose surgical margin of cervix will be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)
No Intervention: 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)
- Bleeding period after surgery in days [ Time Frame: two weeks ]
- Amount of bleeding after surgery [ Time Frame: two weeks ]evaluated by using the Pictorial Bleeding Assessment Chart
- Infection frequency at external genitals, vagina and cervix after surgery [ Time Frame: two weeks ]infection frequency is counted by record of treatment for infectious disease for two weeks after surgery and pelvic examination when the patients is visiting the hospital on the second week after surgery
- Change in life quality after surgery [ Time Frame: 4 weeks prior to, during the period between 14 and 21 days after, and 6 weeks after, respectively ]evaluated three times by using the Medical Outcomes Study Short-Form-36 (SF-36)
- Amount of vaginal discharge [ Time Frame: two weeks ]measuring the amount of vaginal discharge on the day when there is no vaginal bleeding by using a visual analogue scale, the amount will be scored on a scale ranging from 0 to 5 the day when there is no discharge at all is defined as 0, and the day when the patient has experienced the most amount of discharge is defined as 5 on the five-point scale
- Frequency of additional treatment due to bleeding after surgery [ Time Frame: two weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629510
|Korea, Republic of|
|Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|