Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy

Study Overview
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Brief Summary
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Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma) Intervention: Device ( Test group : Guardix-FL, Control group : Interceed) Primary Outcome Measure : Anti-adhesion Rate Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)

Official Title
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Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study

Conditions
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Genital Diseases, Female

Intervention / Treatment
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* Device: Guardix-FL
* Device: Interceed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who sign the written informed consent Women aged between 18 and 44 The patients who are able to participate in clinical trial during the period of study The patients without abnormal figures at the screening laboratory examination The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma) Exclusion Criteria: The patients who took treatments with medical products which might be barrier to evaluate the effectiveness The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants The patients with severe drug allergy The patients with infectious disease on abdominal or pelvic cavity The patients who previously participated in another clinical trials within the past 30 days The patients considered inappropriate for the study The pregnant The patients with severe renal disease The patients with severe systemic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GUARDIX-FL<br>Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day). | Device: Guardix-FL<br> <br> |
| Active Comparator: Interceed<br>Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day). | Device: Interceed<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Adhesion Rate | Adhesion yes or no | Post-Operative Day+4weeks(Second - look) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score | Length of Adhesion x Grade of Adhesion | Post-Operative Day+4weeks(Second-look) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystectomy