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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 : Active, not recruiting
First Posted : December 14, 2015
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center

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


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Cervical Cancer Drug: Tachosil Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

Arm Intervention/treatment
Experimental: Tachosil
The group composed of patients whose surgical margin of cervix will be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)
Drug: Tachosil
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)



Primary Outcome Measures :
  1. Bleeding period after surgery in days [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. Amount of bleeding after surgery [ Time Frame: two weeks ]
    evaluated by using the Pictorial Bleeding Assessment Chart

  2. 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

  3. 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)

  4. 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

  5. Frequency of additional treatment due to bleeding after surgery [ Time Frame: two weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center

Responsible Party: Jeong-Yeol Park, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02629510     History of Changes
Other Study ID Numbers: TACO_1234
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hemorrhage
Carcinoma in Situ
Pathologic Processes
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma