BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- AMH levels 3 months postoperatively
研究概览
简要总结
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.
The 2 conservatives techniques used are:
- The combined technique
- CO2 laser vaporization only
Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.
- •Inclusion Criteria:
- •Age: 18 - 40 years (both inclusive)
- •Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions.
- •Presence of a contralateral endometrioma of ≤ 2cm is allowed
- •Complaining of infertility and/or pain
- •Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery
排除标准
- •Incomplete surgery for the pelvis
- •Contra-indication for the use of contraception (combined or Progesteron only)
- •Use of GnRH analogues preoperatively and in the first 3 months postoperatively
- •(History of) hysterectomy
- •Prior unilateral oophorectomy
- •Pituitary/hypothalamic disorders
- •Suspected malignancy
- •Contralateral endometrioma of >2 cm
- •AMH <0.7 preoperatively
- •Pregnancy
研究组 & 干预措施
The combined technique
First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.
干预措施: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). (Procedure)
CO2 laser vaporization only
CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.
干预措施: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). (Procedure)
结局指标
主要结局
AMH levels 3 months postoperatively
时间窗: 3 months postoperatively
To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).
次要结局
未报告次要终点