The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal… (NCT04672421) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
South Korea107 participantsStarted 2011-04-18
Plain-language 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-treatment control group. Adhesion formations at 8 weeks after the index surgery were compared between the two groups by using the well-defined grade scale and image recording.
Who can participate
Age range20 Years – 80 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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
* Subject…
What they're measuring
1
Comparison of the adhesion rate between the groups