Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Hemorrhage

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Cervical Intraepithelial Neoplasia

The group composed of patients whose surgical margin of cervix will be treated with Tachosil® after a loop electrosurgical excisional procedure (LEEP)

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

Tachosil

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

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.

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

evaluated by using the Pictorial Bleeding Assessment Chart

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

evaluated three times by using the Medical Outcomes Study Short-Form-36 (SF-36)

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

Asan Medical Center

professor

Nervous System Diseases

Wounds and Injuries

Cerebrospinal Fluid Leak

Meningitis

Cerebral Ventricle Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Coagulants

All Drugs and Chemicals

Thrombin

Hemostatics

Group of patients operated on for periventricular lesions with ventricular entry and placement of TachoSil directly over the area of ventricular opening in order to avoid complications.

Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.

TachoSil

Pilar Teixidor Rodriguez, MD, PhD

The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.

A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).

Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).

Primary objectives:

The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.

To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.

Secondary objectives

* Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
* Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
* Incidence of pseudomeningocele \>20cc confirmed with MRI or ultrasound (effectiveness objective).
* Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
* Record the percentage of use of other dural sealants
* Evaluate the cost effectiveness of the product.
* Describe the adverse effects related to the product
* Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
* Assessment of the complications that are avoided: readmissions.

Study period: from December 2020 to December 2023.

Observational Pilot Study With TachoSil as a Ventricular Sealant

To evaluate the effectiveness and the percentage of complications related to the ventricular entry during surgery. Taking into account hydrocephalus, CSF leak, meningitis and pseudomeningocele.

Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP)	NCT02629510	Cervical Intrae... Cervical Cancer	Tachosil	20 Years -	Asan Medical Center
Observational Pilot Study With TachoSil as a Ventricular Sealant	NCT05717335	Intraventricula...	TachoSil	18 Years -	Germans Trias i Pujol Hospital
Observational Pilot Study With TachoSil as a Ventricular Sealant	NCT05717335	Intraventricula...	TachoSil	18 Years -	Germans Trias i Pujol Hospital

Spots Global Cancer Trial Database for tachosil

Every month we try and update this database with for tachosil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tachosil

Every month we try and update this database with for tachosil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tachosil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.