Patients scheduled to undergo surgery for benign gynecologic disease
Conditions
Interventions
GM142(Adhesion Barrier)
Sponsors
GUNZE LIMITED
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged 20 years or older at the time of obtaining an informed consent 2. Patients who are scheduled to undergo laparoscopic surgery, laparoscopic-assisted surgery, or laparotomy for benign gynecologic disease 3. Patients who are fully informed about this study prior to the participation, understand the content, and give a written informed consent of their own free will
Exclusion criteria
Exclusion criteria: (Preoperative criteria) 1. Patients who have a history of surgery in peritoneal cavity, except operation for appendicitis 2. Patients who had or have active pelvic inflammatory disease or peritonitis 3. Patients who are subject to emergency operation 4. Patients who have gelatin hypersensitivity 5. Patients who have a history of severe drug allergy 6. Patients who are severe diabetes or anomaly of saccharometabolism 7. Patients who are suspected of endometriosis of r-ASRM stage III (Moderate) or greater 8. Patients who require chronic treatment with corticosteroids 9. Patients who are scheduled to undergo radiotherapy or chemoradiotherapy during preoperative and postoperative periods 10. Patients who are scheduled to undergo chemotherapy within 2 weeks after surgery 11. Patients who are administered unapproved medications or medical devices within 12 weeks prior to obtaining the informed consent 12. Patients who are pregnant or lactating, or want to become pregnant during the clinical trial 13. Patients who are undergoing dialysis due to hepatic cirrhosis, active hepatitis, or chronic renal failure 14. Patients who are positive for any infection inappropriate for inclusion in the study based on the judgment of the principal investigator or sub-investigators 15. Patients who have psychiatric disease or symptom for which the enrollment in the study is judged unsuitable 16. Any other patients regarded unsuitable by the principal investigator or sub-investigators (Preoperative criteria: In case of laparoscopic myomectomy) 17. Patients whose largest uterine fibroid has been found to be 10 cm or longer in length in preoperative MRI 18. Patients who have been found to have 10 or more uterine fibroids of 1 cm or larger in diameter in preoperative MRI (Perioperative / Discontinuance criteria) 19. Patients who have been found to have endometriosis of r-ASRM score 16 points or over 20. Patients who have not applied GM142
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events within 12 weeks after surgery | — |
Countries
Japan
Contacts
Public ContactMuneaki Ezu
GUNZE LIMITED Medical Division
Outcome results
None listed