DRKS00009511已完成4 期
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
Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie0 个研究点目标入组 58 人开始时间: 2015年10月13日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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