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

NCT02629510 | Unknown Phase 4 DMC

• 1 other identifier: TACO_1234
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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. 1.Primary endpoint:
2. 2.Secondary endpoint:

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Bleeding period after surgery in days

  two weeks

Secondary Outcomes (5)

• Amount of bleeding after surgery

  two weeks

• Infection frequency at external genitals, vagina and cervix after surgery

  two weeks

• Change in life quality after surgery

  4 weeks prior to, during the period between 14 and 21 days after, and 6 weeks after, respectively

• Amount of vaginal discharge

  two weeks

• Frequency of additional treatment due to bleeding after surgery

  two weeks

Study Arms (2)

Tachosil

EXPERIMENTAL

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 Tachosil

NO INTERVENTION

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

Interventions

Tachosil DRUG

Tachosil

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

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

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39842025 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 14, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

KR (1)