The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
Condition: Laparoscopy; Tissue Adhesion, Surgery-Induced; Leiomyoma of the Uterine Body
MeSH terms: Leiomyoma; Myofibroma; Tissue Adhesions
Study type: Interventional

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.
    

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 screening was conducted for the subject who signed an informed consent form. Subjects
      who met the inclusion criteria were randomly assigned into either treatment (Medicurtain®) or
      control group.

      Each subject visit clinic for follow-up examination 1week (Visit 2) and 8 weeks (Visit 3)
      after the index surgery and before the visit subjects were received phone calls. Since the
      target population was the patient who scheduled elective total laparoscopic hysterectomy,
      subjects who met the inclusion/exclusion criteria after the examination for the surgery
      signed on the informed consent at Visit 1 (Baseline: 0 day) and randomly assigned either into
      the treatment and control group.

      At visit 2 (1week±2days), 1week after the index surgery adverse events and general health
      were examined. At visit 3 (8week±5days), 8 weeks after the index surgery, the investigator
      inserted endoscope into abdominal cavity and took video clip and still images. If it was
      necessary, adhesion was removed surgically. An independent evaluator evaluated the records
      and graded the adhesion rate and its severity according to the grading system. If it was
      difficult to collect images with endoscope, the investigators recorded his observation for
      statistical analysis.

      The investigator inserted endoscope into abdominal cavity and took video clip and still
      images at 8weeks after total laparoscopic hysterectomy to evaluate the adhesion formation and
      its grade. An independent evaluator evaluated the records and graded the adhesion rate and
      its severity according to the grading system. If it was difficult to collect images with
      endoscope, the investigators recorded his observation for statistical analysis. The adhesion
      grading system was proposed by American Fertility Society (AFS) in 1988, grades adhesion with
      Grade 0, Grade 1, Grade2 and Grade 3. Grade 0 means there is no adhesion formation, Grade
      1~Grade 3 means there is adhesion formed, severity increases with the grade. Adhesion rate
      and grade were evaluated between the treatment and control groups suing Grade 0~3 scales.

      General safety of the study device was evaluated based on the adverse event rate, laboratory
      tests, ECG test. The laboratory tests were conducted before and after the index surgery to
      evaluate whether the device cause toxicity such as hepatic and renal toxicity for safety
      evaluation.
    

Intervention name(s): Medicurtain®; Placebo
Intervention type(s): Device; Device
Intervention description(s): Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery); No device after laparoscopic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medicurtain®; Sodium hyaluronate; Hydroxyethylstarch; Anti-adhesion barrier