Randomised, controlled clinical study with patients with endometriosis and the desire to have children – Comparison between peritoneal ablation by excision only and excision with the application of an adhesionbarrier
- Conditions
- N80.9N73.6Endometriosis, unspecifiedFemale pelvic peritoneal adhesions
- Registration Number
- DRKS00009511
- Lead Sponsor
- Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
- Brief Summary
58 female patients were included in the analysis. The patients were 29.94 ± 5.05 years old and had a BMI of 26.0 ± 5.36 kg/m². 20% of the patients had at least one relative with endometriosis. 51% of patients had previously undergone surgery for endometriosis. 43% of patients had stage I endometriosis, 24% had stage II endometriosis, and the remaining patients were distributed among stages 0, IV, and V (mean 15.0 ± 27.25 points in the rASRM classification). Pre-existing adhesions were detected in 49% of patients (mean 10.06 ± 23.01 points in the rASRM adhesion score). No adverse events occurred. Further analysis on pain and pregnancy will be performed in the coming months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 58
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the pregnancy rate 12 months after stopping treatment
- Secondary Outcome Measures
Name Time Method Quantitative Parameters:- Duration of surgery; - Assessment of pain before and 12 Months after the Treatment<br><br>Descriptive Parameters: Applicability of the adhesions profilaxis gel (Hyalobarrier)on the 23 different posible localization of the endometriosis foci. <br><br>Visual analogue scale to assess pain:<br>Parameters: dysmenorrhea, pelvic pain independent of the menstrual period, lower back pain, Rectal pain / pain associated with defecation, dyspareunia<br><br>The subjects are asked about their average pain in the last three months.