uterine fibroids
Conditions
Interventions
UFS-QOL:Two questionnaires will be administered before surgery and either 6 months after surgery or at discontinuation/transfer
Sponsors
Koga Kaori
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with uterine fibroids 2)Patients scheduled to undergo uterine fibroid enucleation 3) Patients who agree to administer RAM by self-expensed medical care 4)Patients aged 18 years or older at the time of informed consent 5)Patients who gave written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1)Those with uterine fibroids 20 cm or larger in diameter on the last imaging study 2)Those with at least 15 MRI measurable (>= 1 cm) fibroids 3)Patients previously treated for pelvic inflammatory disease 4)Patients requiring simultaneous removal of ovarian cysts larger than or equal to the long 5 cm 5)Patients with suspected malignancy 6)Patients who are expected to have severe adhesions in the abdominal cavity based on previous surgery, etc. 7)Pregnant patients 8)Other patients who are judged by the investigator to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative adverse events (all adverse events, vascular injury with repair, organ injury with repair, bleeding) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Rate of conversion to open or laparoscopic surgery 2)Surgical results (size, weight, number of uterine fibroids removed, operation time, intraoperative blood loss, blood transfusion or not) 3)Postoperative recovery (postoperative hospital stay) 4)Postoperative pain (pain NRS score/presence of treatment for pain) 5)Postoperative complications (all complications/rebleeding/hematoma formation/abdominal wall wound infection/intrauterine infection/intrauterine cavity adhesion/muscle thinning/intestinal obstruction/late organ injury/other) 6)Rates of reoperation/readmission/unplanned revisits 7)Myometrial evaluation 8)QOL(UFS-QOL) 9)Learning curve | — |
Contacts
Public ContactHiroshi Ishikawa
Chiba University Hospital
Outcome results
None listed