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 Use of an Adhesionbarrier
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pregnancy rate
研究概览
简要总结
Endometriosis is a common disease of women in the reproductive age and is an important cause for female infertility. Endometriosis is often associated with the development of adhesions which further compromises the fertility of the affected women. The main purpose of this study is to investigate the pregnancy rate one year after excision of endometriosis and application of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the patients will receive traditional endometriosis treatment with the excision of the endometriotic lesions only. The other half will additionally receive a gel which can reduce adhesion formation (Hyalobarrier®). Further study objective is the investigation in the development of different types of endometriosis-associated pain over a period of one year. Potential study participants are women with endometriosis-associated pain and with a desire to have children. It will be investigated in the study if the use of Hyalobarrier® will result in a higher pregnancy rate due to reduced adhesion development.
详细描述
Design: Prospective, monocentric, comparative, randomized, semi-blind.
There will be 30 subjects in each arm, who will be followed 15 months after surgery.
Half of the patients will receive standard laparoscopic excision of the endometriotic lesions only. The other half, after the excision of the endometriosis foci, will receive 10 cc of an antiadhesion agent which contents hyaluronic acid gel (Hyalobarrier®).The subjects will be hospitalized after surgery for at least 2 days.
A Vas-Scala will be given to the subjects to estimate the pain before, after surgery and one year after treatment. The participants will record the values each three months after surgery.
All subjects will be asked by telephone for the VAS-scala values and for pregnancy (Date of Initiation, clinical evolution)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 a desire to have children;
- •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
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
结局指标
主要结局
Pregnancy rate
时间窗: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)
次要结局
- Endometriosis-associated pain(One year after completion of endometriosis treatment)
研究者
Prof. Dr. Dr. med. Rudy Leon De Wilde
Professor Dr. Dr. med.
Pius-Hospital Oldenburg