Additional Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve During Laparoscopic Ovarian Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Serum anti-Mullerian hormone (AMH) level at 3 months
研究概览
简要总结
Introduction : The most common technique used for ovarian cystectomy is the stripping technique. After stripping the cyst wall, the subsequent bleeding of the ovarian stromal wound is usually controlled by bipolar coagulation or/and by suturing. However, hemostasis achieved with bipolar coagulation could result in damage to the ovarian reserve. To avoid damage to healthy ovarian tissue, hemostasis using various topical hemostatic agents has been introduced to control post- cystectomy ovarian wound bleeding. Among these, FloSeal (Baxter Healthcare Corporation, Deer- field, IL, USA) is a hemostatic sealant composed of a gelatin-based matrix and thrombin solution.
Aim: The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Müllerian hormone (AMH).
Methods: A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions (n = 80), Montpellier University Hospital and Nimes University Hospital, France. Patients were randomly divided into two groups treated with either a topical hemostatic sealant (Floseal) or bipolar coagulation for hemostasis. Preoperative, 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Cyst diameter between 3 and 10cm
- •Preoperative AMH level >0,5ng/ml
- •Understanding and acceptance of the protocol
排除标准
- •Post-menopausal status
- •Any suspicious finding of malignant ovarian disease
- •Change of contraception method leading to AMH variation
- •Allergy to bovine products found before inclusion
- •Pregnancy
- •Patient who has already participated in the protocol
- •Person deprived of liberty by judicial or administrative decision
- •Person protected by law, under tutorship or curatorship
- •Patient participating in another interventional research on the human person in progress
- •Refusal of participation after a period of reflection
- •Patient not affiliated or beneficiary of a national health insurance system
结局指标
主要结局
Serum anti-Mullerian hormone (AMH) level at 3 months
时间窗: 3 months after the cystectomy
A biological assessment with determination of the serum AMH level will be carried out for each patient, 3 months postoperatively.
Serum anti-Mullerian hormone (AMH) level at 6 months
时间窗: 6 months after the cystectomy
A biological assessment with determination of the serum AMH level will be carried out for each patient, 6 months postoperatively.
Serum anti-Mullerian hormone (AMH) level preoperative
时间窗: Between 2 and 17 days before cystectomy
A biological assessment with determination of the serum AMH level will be carried out for each patient during the preoperative consultation.
次要结局
- Time to achieve hemostasis(From the end of the cystectomy to the end of hemostasis (up to 1 hour))
- Use of additional hemostatsis technique(From the end of the cystectomy to the end of hemostasis, during surgery)
- Blood loss(From the start of the surgery to the end of hemostasis)
- Intraoperative adverse effects(From the end of the cystectomy to the end of hemostasis)
- Revision surgery for bleeding at the operative site(From the end of the cystectomy to the end of hemostasis)