Evaluating Ovarian Reserve After Conventional Laparoscopy Versus Robotic Surgery for Bilateral Endometrioma: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in serum AMH (sAMH) from baseline to 6 months after the operation
研究概览
简要总结
The aim of this study is to perform a randomized study investigating AMH recovery comparing robot-assisted laparoscopy and conventional laparoscopy in patients with bilateral ovarian endometrioma. It is hypothesized that in patients with endometriomas, a robot-assisted approach may provide improved instrument navigation resulting in more precise dissection and therefore removal of less healthy ovarian tissue compared to conventional laparoscopy. AMH is the most widely used parameter for predicting functional ovarian reserve. Postoperative AMH levels were associated with the number of follicles in specimens due to the removal of ovarian cortex during surgery . Furthermore, the reduction in AMH level after surgery is higher in bilateral endometrioma.
The investigators hypothesize, on the basis of Lee at al., 2020, that patients with bilateral endometrioma will have significantly higher AMH levels 6 months after robot-assisted laparoscopy than patients who were treated with conventional laparoscopy.
Therefore, the primary outcome is postoperative serum AMH level recovery in patients undergoing conventional laparoscopy versus robot-assisted laparoscopy.
Aims: The aim of this study is to investigate postoperative differences in ovarian reserve differing between robot-assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery.
Study population: The study population will consist of women aged between 18 and 45 years who are referred to our gynecologic outpatient clinic due to bilateral endometrioma. Women with an indication for surgery can be included in this trial.
Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is postoperative serum AMH (sAMH) level recovery. This will be evaluated 6 months after surgery.
详细描述
Experimental Plan
Study design This trial is a prospective, randomized-controlled study investigating postoperative differences in ovarian reserve differing between robot-assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery. Postoperative follow-up will take place after 6 months. All women referred to our department for endometrioma will undergo clinical examination by a senior surgeon experienced in endometriosis as well as ultrasound. All patients with bilateral endometrioma will be included. Complementary examinations, such as cystoscopy or renal sonography will be performed in women with suspected involvement of urinary tract.
In women with pregnancy intention and endometrioma, an exhaustive assessment of the disease will systematically be performed before deciding between primary surgery and primary assisted reproductive techniques.
Gynecological examination will be performed at each visit. Ovarian reserve will be evaluated using antral follicle count (AFC) via transvaginal sonography, anti-Mullerian hormone (AMH), follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels and ovarian volume.
Follicle number will be evaluated by pathologists in the histologic tissue sections.
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
- •Bilateral endometrioma
- •Surgical endometriosis resection is planned
- •sAMH > 1.0 ng/ml
排除标准
- •History of malignant diseases
- •History of adnexal surgery
- •Subject is unable or unwilling to participate
- •Postmenopausal women
研究组 & 干预措施
robotic-assisted laparoscopy
The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. An umbilical port was placed for the laparoscope (10/12 mm), a 5-mm port for the assistant, and two to three ports (5/8 mm) for the robotic arms.
干预措施: robotic-assisted laparoscopy (Procedure)
conventional laparoscopy
Laparoscopic-assisted cystectomy of endometrioma will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery.
干预措施: Conventional laparoscopy (Procedure)
结局指标
主要结局
Change in serum AMH (sAMH) from baseline to 6 months after the operation
时间窗: 6 months after the operation
postoperative sAMH (6 months after the operation) compared to preoperative sAMH
次要结局
- Change in antral follicle count (AFC) from baseline to 6 months after the operation(6 months after the operation)
- change in ovarian volume from baseline to 6 months after the operation(6 months after the operation)
- change in follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from baseline to 6 months after the operation(6 months after the operation)
- rate of intraoperative adverse events(1 day)
- rate of postoperative adverse events(4 weeks)
- operation time(1 day)
- length of hospitalization (following the operation)(2 weeks)
- blood loss(1 day)
- laparotomic conversion rate(1 day)
- follicle number in the histologic tissue sections(1 day)
- change of the Endometriosis Health Profile (EHP) EHP-30 from baseline to 6 months after the operation(6 months after the operation)
- 10-point Likert scale for cosmetic satisfaction(6 months after the operation)
- Disease recurrence rate up to 12 months after surgery(12 months after the operation)
研究者
Christine Bekos
Principan Investigator
Medical University of Vienna