Uterine leiomyoma, ovarian tumor, tubal adhesion, caesarotomy
Conditions
Interventions
Trehalose-based tissue adhesion preventive device is sprayed over the whole operative field or abdominal cavity during laparoscopical or open abdominal surgery due to uterine leiomyoma, ovarian tumor
Sponsors
The University of Tokyo Hospital Department of Obstetrics & Gynecology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 Patients who use Seprafilms during laparoscopical or open abdominal surgery due to uterine leiomyoma, ovarian tumor or tubal adhesion, or during caesarotomy. 2 Patients who can observe the protocol and are willing to and able to submit written informed consent. 3 Patients who have signed the written informed consent form approved by Institutional Review Board before subject screening.
Exclusion criteria
Exclusion criteria: 1 Pregnant women, except for cesarean section patients 2 Patients who have received intravenous drip injections and, or perfusates containing dextran, heparin, corticosteroids or nonsteroidal antiinflammatory drugs. 3 Patients who chronically need to receive corticosteroids, or patients who are administered corticosteroids and, or nonsteroidal antiinflammatory drugs within 24 hours prior to surgeries. 4 Patients who have been treated with Interseeds or PRECLUDE surgical membranes or have received other antiadhesion treatments. 5 Patients in the physical conditions that can affect evaluation of safety and efficacy of the present device or Seprafilm. 6 Patients with histories of severe drug allergies. 7 Patients who have received other research products that might affect evaluations of safety and efficacy of the present device during the trial period. 8 Patients with active pelvic inflammatory diseases or peritonitis. 9 Patients who have had open abdominal operations. 10 Patients whose SGOT, SGPT or bilirubin level is more than 20 percent higher than each upper limit. 11 Patients whose BUN and creatinine level are more than 30 percent higher than each upper limit. 12 Patients with severe diabetes mellitus with over 8 percent of HbA1c. 13 Patients who are judged to be inappropriate for the study by doctors in their charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmation of safety and efficacy of trehalose-based tissue adhesion preventive devices | — |
Countries
Japan
Contacts
Public ContactToshihiro Fujiwara
The University of Tokyo Hospital Department of Obstetrics & Gynecology
Outcome results
None listed