Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Ovarian reserve
研究概览
简要总结
In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).
详细描述
The aim of the present study was to determine which hemostatic procedure (hemostatic suture or electrocautery) may be less harmful after laparoscopic cystectomy, based on the longterm status of the ovarian reserve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Allocation and concealment will be done by sequentially sealed opaque envelopes. 60 envelopes will be numbered serially from 1 to 60, 30 envelopes will contain the letter c and the other 30 will contain the letter S.
In each envelope, the corresponding letter which donates the allocated group will be put according to the randomization table and them all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regular menstrual cycle.
- •Unilateral ovarian cyst clinical & us finding as endometriotic cyst.
- •C/O of pelvic pain.
- •No medications (oral pills & hormonal drugs) in the past 3 monthes before enrollement.
- •No evidence of endocrine disorders (DM, Thyroid dysfunction,hyper prolactenemia, congenital adrenal hyperplesia, cushing's syndrome or adrenal insufficiency)
- •No previous adnexial surgery.
- •Pathology diagnosis of excised ovarian tissue (endometriotic cyst)
- •Appropriate medical condition for laparoscopic surgery.
- •Completely understand the process of the study with written consent.
排除标准
- •PCO according to Rotterdam criteria.
- •Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.
- •Previous ovarian surgery.
- •Suspected ovarian malignancy.
- •Patient whose histopathology showed benign cyst apart from endometrioma.
- •Irregular menstrual cycles.
- •Post menopausal status.
- •Bilateral ovarian cyst.
- •AMH < 0.5 ng/ml.
- •Premature ovarian failure in family.
研究组 & 干预措施
Suturing group
The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing.
The running suture starting from central area, around the ovarian hilus to peripheral tissue, will be performed with intraovarian knots to re-approximate the edges to achieve satisfying hemostasis. Knots will not be detectable on the ovarian surface for prevention of adhesion. Mean time for hemostasis of ovary was recorded in a form. The cyst wall will be removed from the abdomen by means of an endobag. All resected cyst walls will be sent to the pathology laboratory, to confirm the histopathology of endometriosis.
干预措施: 2-0 polyglican absorbable sutures (Device)
Bipolar group
In bipolar coagulation group, after stripping the ovarian cyst wall, bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). In laparoscopic suturing group, no bipolar coagulation will be performed during or after stripping the ovarian cyst wall.
干预措施: Diathermy (Device)
结局指标
主要结局
Ovarian reserve
时间窗: 3 months
By measuring Anti-mullerian hormone
次要结局
未报告次要终点
研究者
Mohamed abd elfatah elsenity
Lecturer of obstetrics and gynecology
Ain Shams University