DRKS00003697进行中（未招募）未知
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 help of the Jet Grasper as well as the use of an adhesionbarrier
Pius-Hospital Oldenburg,Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie0 个研究点目标入组 58 人开始时间: 2012年5月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
研究概览
简要总结
58 subjects have completed the 12 months follow up period and were included in the interim analysis. Two groups of subjects were evaluated in the interim analysis in which cases received an anti-adhesion agent during the endometriosis laparoscopy and a control group which received no anti adhesion agent during laparoscopy. The primary outcome variables were pregnancy outcome and pain 12 months post surgically. The secondary outcome variables were hospital duration, operation time and complication rate. The results showed that there was no significant difference between the two groups in any of the outcome variables. This indicates that applying a barrier gel during laparoscopic endometriosis therapy has no effect on the outcome of the disease
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 50 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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