N80
Conditions
Interventions
Group 1: excision of endometriotic lesions with the help of the Jet Grasper
Group 2: excision of endometriotic lesions with the help of the Jet Grasper plus application of Hyalobarrier®
Sponsors
Pius-Hospital Oldenburg,
Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Women over 18 years with endometriosis-associated pain, like dysmenorrhea, dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only one criterion needs to be fulfilled for study inclusion); Participants are in good general health except for endometriosis related problems; Except for endometriosis, no existence of an obvious diseases which could cause chronic pain or which could cause abdominal pain; The participant must have an urgent desire to have children and must agree not to take contraceptive agents during a period of one year after the second look laparoscopy; Participants must be able to give their consent and must understand the risks associated with a participation in the study; There must be a signed and dated informed consent which was accepted by the local ethic committee; Endometriosis in the area of the tubo-ovarian unit
Exclusion criteria
Exclusion criteria: Existent pregnancy including ectopic pregnancy; Identification of other causes for the discomfort; Chronic diseases, except endometriosis, which require continuous pain therapy; Previous application of GnRH analogues 6 month prior to study; Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation; Planned additional general surgical procedures during the operation for removal of the endometriotic lesions; Absence of endometriosis at laparoscopy; Partial resection of the bowel or urinary bladder for removal of endometriosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesion development in the area of the tubo-ovarian unit (assessment during a Second-look-laparoscopy 3 month after the first laparoscopy) | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of surgery, adhesion score of 23 anatomical sites (assessment during a Second-look-laparoscopy 3 month after the first laparoscopy), assessment of pain before the initial laparoscopy, before the second look laparoscopy(SLL), 3, 6 and 9 month after SLL; pregnancy rate 12 month after SLL, number of bleedings that require coagulation in the area of the tubo-ovarian unit, overall number of bleedings that require coagulation | — |
Countries
Germany
Contacts
Public ContactRudy Leon De Wilde
Pius-Hospital Oldenburg, Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Outcome results
None listed