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

NCT02629510UNKNOWNPHASE4INTERVENTIONAL

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

Key Facts

Lead Sponsor

Asan Medical Center

Enrollment

268

Start Date

2015-01-01

Completion Date

2017-08-01

Study Type

INTERVENTIONAL

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

Interventions

Tachosil

Conditions

Cervical Intraepithelial NeoplasiaCervical Cancer

Eligibility

Age Range

20 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Bleeding period after surgery in days

Time frame: two weeks

Secondary Outcomes

Amount of bleeding after surgery

evaluated by using the Pictorial Bleeding Assessment Chart

Time frame: 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

Time frame: two weeks

Change in life quality after surgery

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

Time frame: 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

Time frame: two weeks

Frequency of additional treatment due to bleeding after surgery

Time frame: two weeks

Locations

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

Linked Papers

2025-01-22

Hemostatic Efficacy of TachoSil in Loop Electrosurgical Excisional Procedure: A Prospective Randomized Controlled Study

Objective The aim of the study was to evaluate the hemostatic efficacy of the fibrin sealant patch (TachoSil) after loop electrosurgical excision (LEEP) and its influence on other complications and quality of life (QoL). Materials and Methods This single-blind, prospective, randomized study involved patients undergoing LEEP with or without TachoSil (1:1) between August 2014 and August 2015 in Asan Medical Center, Korea. Primary outcome measures were bleeding duration and the frequency of additional treatment owing to vaginal bleeding within 2 weeks after LEEP. Secondary outcome measures were vaginal bleeding volume using pictorial blood loss assessment chart (PBAC) score, the amount of vaginal discharge, the frequency of external genitalia, vaginal, and cervical infections within 2 weeks after LEEP, and changes in QoL. Results Of the 140 patients enrolled, 126 (90.0%) were successfully followed up and analyzed. The median vaginal bleeding duration and frequency of additional treatment owing to vaginal bleeding showed no significant difference in the TachoSil applied and nonapplied groups (p = .96 and p = .61, respectively). In addition, no significant difference was also observed in vaginal bleeding volume between 2 groups (p = .64). In subgroup analysis for patients who underwent large LEEP (the longest dimension of ≥2 cm), significant improvement was observed at physical functioning in QoL at 2–3 (p = .03) and 6 weeks (p = .03) after LEEP of the TachoSil applied group, compared to the nonapplied group. Conclusions TachoSil did not demonstrate significant hemostatic efficacy after LEEP. However, TachoSil improved patient recognition on physical function in patients who underwent large LEEP.

Linked Investigators

Jeong-Yeol Park