Intra-operative Ultrasound Guided Laparoscopic Ovarian Cystectomy (UGLOC) as a Method of Fertility Preservation in the Management of Benign Ovarian Cysts: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Antral Follicle Count (AFC) (n)
研究概览
简要总结
Title:
Intra-operative ultrasound guided laparoscopic ovarian cystectomy (UGLOC) as a method of fertility preservation in the management of benign ovarian cysts.
Background:
Approximately 10% of women in the United Kingdom (UK) will undergo surgery for the presence of an ovarian mass during their lifetime. Ovarian surgery, however, is not without risks and can potentially harm healthy ovarian tissue surrounding the cyst, resulting in reduced reproductive potential (the ability of the ovary to produce eggs for fertilisation). Surgical methods to preserve healthy ovarian tissue and improve the chances of successful pregnancy post-operatively are known as Fertility Preserving Surgery (FPS). Evidence suggests that a novel approach of FPS involving the removal of an ovarian cyst performed under ultrasound guidance improves the differentiation between the healthy ovarian tissue and the ovarian cyst. As such, the surgeon can remove the cyst alone, whilst limiting disruption to the healthy surrounding ovarian tissue.
Aim:
The purpose of this study is to assess if surgical removal of an ovarian cyst performed under ultrasound guidance improves the reproductive potential of the ovaries, when compared to surgery performed without ultrasound guidance.
Eligibility
All patients of reproductive age (18-45 years old) with ultrasound features suggestive of a benign ovarian cyst requiring surgical treatment (removal of the cyst). Patients diagnosed with benign ovarian cysts, deemed to be non -harmful to the patient if left untreated, of the following classifications can be included in the study: dermoid, simple cyst, serous cystadenoma, mucinous cystadenoma or endometrioma.
Design:
A multicentre randomised controlled trial. Women across Imperial College London Healthcare and University College London Trusts will be allocated to a surgical treatment group at random: 1) laparoscopic ovarian cystectomy performed without ultrasound guidance (control group) or 2) ultrasound guided laparoscopic ovarian cystectomy performed with ultrasound guidance (fertility preservation surgery: intervention group).
Duration:
3 years
详细描述
Background:
The use of intra-operative ultrasound has been widely implemented amongst other specialties. However, within gynaecological surgery, it is not as commonly recognized, despite evidence that it can be used as an adjunct to improving minimally invasive surgical techniques. This is primarily due to the improved visualization of the operative field, which can assist more technically difficult surgical procedures, thus minimizing intra-operative complications. The application of ultrasound guidance within gynaecological procedures have included predominantly ovarian cyst aspiration, in vitro fertilization and removal or insertion of intra-uterine devices. Although pre-operative imaging provides procedural planning, it cannot compare to the information gained from real time imaging. For example, in previous studies, intra-operative ultrasound detected more myomas during myomectomy than pre-operative transvaginal imaging. Furthermore, it provides the potential to assess lesion margins, ensuring resection of pathology is complete with negligible damage to surrounding healthy tissues. This is consistent with a recent systematic review, which also demonstrated that albeit a novel technique, amongst various case series, pathology can be safely resected without incurring injury to healthy reproductive tissue. Therefore, intra-operative ultrasound has the potential to improve surgical accuracy, reduce complications and improve patient safety. The application of intra-operative ultrasound as an adjunct to fertility sparing surgery has not been widely researched, with only a few case series reporting surgical outcomes on patients undergoing treatment for pre-malignant or malignant pathology. The aim of this study therefore, is to determine the efficacy of this surgical technique in the management of benign pathology, including the surgical resection of ovarian cysts.
Hypothesis:
Intra-operative ultrasound will prove a significant method of fertility preservation surgery, as measured by a significantly reduced decrease in Anti-Mullerian Hormone (AMH) and antral follicle count (AFC) at 3 and 6 months post-operatively, when compared to the control group.
Study Design:
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
- None
盲法说明
Non-blinded study
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients of reproductive age with a diagnosis of a benign ovarian cyst requiring surgical management.
- •This includes cysts defined as dermoid, teratoma, simple cyst, functional, serous cystadenoma or mucinous cystadenoma from the initial diagnostic ultrasound.
- •A strict criterion for the US diagnostic features will include the following:
- •Cyst size ≥3cm; ≤10cm
- •The International Ovarian Tumour Analysis for benign features (IOTA B) only:
- •Unilocular
- •Solid components: largest diameter ≤7mm
- •Acoustic shadows
- •No blood flow
- •Smooth multilocular cyst: largest diameter ≤10cm
- •Specifically:
- •Pregnant patients can be included but will be analysed separately
- •For patients selected for surgery, delay of surgery is not an exclusion criterion for this study, but for selected objectives we will use only those patients in whom surgery was performed within 180 days after the ultrasound examination
- •With regards to age, patients can be selected only if 18-50 years old.
- •Patients whom only underwent transabdominal scanning can be included in the study, but will be analysed separately
排除标准
- •Cysts that are deemed to be clearly physiological and less than <3 cm in maximum diameter are not eligible for inclusion
- •Cysts ≥11cm in maximum diameter
- •Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain).
- •Any cyst with features of malignancy
- •The denial or withdrawal of written informed consent
- •Women of post- menopausal or peri-menopausal status
结局指标
主要结局
Antral Follicle Count (AFC) (n)
时间窗: 3 years
Post operative AFC will be measured at 3 and 6 months post surgery.
Anti-Mullerian Hormone (AMH) (pmol/L)
时间窗: 3 years
Post operative AMH level will be measured at 3 and 6 months post surgery.
次要结局
- Length of hospital stay (days)(3 years)
- Presence of intra-operative cyst rupture (Yes/No)(3 years)
- Duration of surgery (minutes)(3 years)