Clinical trial · Interventional
The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tachosil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tachosil
- description
- The group composed of patients whose surgical margin of cervix will be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)
- interventionNames
- Drug: Tachosil
- type
- NO_INTERVENTION
- label
- No Tachosil
- description
- The group composed of patients whose surgical margin of cervix will NOT be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)
Primary outcomes (1)
- measure
- Bleeding period after surgery in days
- timeFrame
- two weeks
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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