N80.9 N73.6
Conditions
Interventions
Group 1: Patients will have ablation of the endometriosis foci by excision only.
Group 2: Patients will have ablation of the endometriosis foci by excision as well as the apliction of the adhesionsbar
Sponsors
Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Preoperative inclusion criteria: - Women aged > 18 years with endometriosis-associated symptoms such as dysmenorrhea, dyspareunia, pelvic pain, back pain, Rectal, Defecation pain (the presence of individual complaints are accepted as an inclusion criterion) - Subjects are in a good general state of health - Up to endometriosis can be no other obvious diseases associated with chronic pain or other cause of abdominal pain - The subjects have reproductive desire - Subjects understand the course of the study and agree to participate - The subjects must be the capacity to consent, that is, they must understand the risks and benefits of the study and are free to agreement to participate in the study - There is a written consent form, by hand filled and signed, which has been confirmed by the competent ethics committee before. Intraoperative inclusion criteria: - Pelvic Endometriosis
Exclusion criteria
Exclusion criteria: Preoperative exclusion criteria: - Existing pregnancy, including an ectopic pregnancy - In clinical examination there are findings of other causes of complaints - Chronic diseases different of endometriosis which requires pain management - Pre-treatment with GnRH analogues in a period of 6 months prior to study entry - Use of systemic corticosteroids or antineoplastic drugs and / or performing an irradiation - Planned additional general surgeries during the same surgery for endometriosis Intraoperative exclusion criteria: - no visible endometriosis foci at laparoscopy - Evidence of an existing pregnancy, including a ectopic pregnancy - Evidence of other causes of symptoms such as pelvic or abdominal infection, active or suspected malignancy, which are not associated with endometriosis - The need for resection of intestinal segments to remove the endometriosis foci - The need for resection of portions of the urinary bladder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the pregnancy rate 12 months after stopping treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative Parameters:- Duration of surgery; - Assessment of pain before and 12 Months after the Treatment Descriptive Parameters: Applicability of the adhesions profilaxis gel (Hyalobarrier)on the 23 different posible localization of the endometriosis foci. Visual analogue scale to assess pain: Parameters: dysmenorrhea, pelvic pain independent of the menstrual period, lower back pain, Rectal pain / pain associated with defecation, dyspareunia The subjects are asked about their average pain in the last three months. | — |
Countries
Germany
Contacts
Public ContactAngelika Larbig
Pius-Hospital Oldenburg Abteilung Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Outcome results
None listed