N80.9
Conditions
Interventions
Group 1: The intervention group receives 4DryField® PH, which is applied surgically invasively for hemostasis. The application is done as required to treat all sources of bleeding. The required amount
Sponsors
Universitätsklinikum Carl Gustav Carus
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Uni- or bilateral endometrioma resection 2. Written consent to participate in the study 3. Age: 18 – 49 years 4. Pre-operative AMH concentration 0.4-8.0 µg/l (without influence of hormone treatments) 5. Endometrioma size = 3 cm (in case of bilateral endometrioma this criterion must be fulfilled on both sites)
Exclusion criteria
Exclusion criteria: 1. Pregnant patients 2. Patients without necessity for hemostatic measures intra-operatively 3. #ENZIAN score of T3 4. Necessity for an ovariectomy 5. No histological confirmation of an endometriosis cyst 6. Coagulation disorder or taking anticoagulants 7. No participation of the AMH determination after 6 months (primary endpoint) 8. Patient is incapable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The relative AMH value, calculated as difference of the value six months postoperatively compared to the preoperative value. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The relative AMH value, calculated as difference of the value three months postoperatively compared to the preoperative value. 2. Blood loss during the endometrioma resection. 3. The frequency of postoperative complications up to six months after endometrioma resection. 4. The ovarian volume three and six months after endometrioma resection. 5. The number of antral follicles three and six months after endometrioma resection. 6. The concentration of Gonatropine FSH (Follicle-Stimulating Hormone) and LH (Luteinizing Hormone) three and six months after endometrioma resection. 7. The concentration of inhibin B three and six months after endometrioma resection. 8. The heart rate 20 seconds after application of the hemostatic method, measured as change compared to the value directly before treatment. Additionally, the value after 2 minutes is evaluated the same way. | — |
Countries
Germany
Contacts
Public ContactRazvan Petru Derihaci
Universitätsklinikum Carl Gustav Carus
Outcome results
None listed