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

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

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

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Drug: Tachosil

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
• Enrollment (Anticipated): 268
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bleeding period after surgery in days	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of bleeding after surgery	evaluated by using the Pictorial Bleeding Assessment Chart	two weeks
Infection frequency at external genitals, vagina and cervix after surgery	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	two weeks
Change in life quality after surgery	evaluated three times by using the Medical Outcomes Study Short-Form-36 (SF-36)	4 weeks prior to, during the period between 14 and 21 days after, and 6 weeks after, respectively
Amount of vaginal discharge	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	two weeks
Frequency of additional treatment due to bleeding after surgery		two weeks

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 27, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Neoplasms; Uterine Cervical Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Hemorrhage
• Other Study ID Numbers: TACO_1234