Status:
COMPLETED
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
Lead Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Laparoscopy
Tissue Adhesion, Surgery-Induced
Eligibility:
FEMALE
20-80 years
Phase:
NA
Brief Summary
This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-...
Detailed Description
This study was designed as multi-center, randomized, evaluator-blinded, comparative study. Subjects were woman between 20\~80 years of age reserved with total laparoscopic hysterectomy. Subject screen...
Eligibility Criteria
Inclusion
- Woman who is between 20\~80 years of age.
- Woman who is reserved with total laparoscopic hysterectomy like:
- Malignant neoplasm of cervix
- Malignant neoplasm of uterine body
- Unspecified malignant neoplasm of cervical region
- Other and unspecified malignant neoplasm of the female reproductive system
- Carcinoma in situ of the cervix
- Other and unspecified carcinoma in situ of the reproductive system Leiomyoma of the uterus
- Other benign neoplasms of uterus
- Neoplasm of uncertain behavior of uterus
- Endometriosis
- Polyp of corpus uteri
- Other noninflammatory disorders of uterus, except cervix
- Cervical dysplasia
- Congenital malformations of uterus and cervix
- Injury of uterus
- Woman who signed and informed consent.
Exclusion
- Presence of tumor or inflammatory disease in other organs after the laparoscopy or laparoscopic surgery
- Subjects with a history of open surgery or laparoscopic surgery
- Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator
- Subject who is not eligible for re-operation or laparoscopy after laparoscopic surgery
- Subjects using coagulant and subjects with lymphoid disease
- Diabetic subjects administrating oral or parenteral glucose-lowering drugs
- Patients with autoimmune diseases or immune disorders
- Liver disease or kidney disease, surgical subjects including open surgery of gastrointestinal or urinary system
- Subjects judged as inadequate by investigator
Key Trial Info
Start Date :
April 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04672421
Start Date
April 18 2011
End Date
May 9 2012
Last Update
September 29 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul Asan Medical Center Gil, Songpa-gu, South Korea