Clinical trial: The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study) (NCT04672421)

Eligibility criteria:
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

          -  Subjects judged as inadequate by investigator
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 1