Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- transplant sucess rate
研究概览
简要总结
Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.
详细描述
Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
- •At least one pregnancy before
排除标准
- •comorbidities that contraindicate a surgical procedure
- •Women who do not understand the study;
- •Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
- •ABO blood test mismatch between donor and recipient patient.
研究组 & 干预措施
Uterus Transplantation
Patients undergo transplantation of the uterus from live donor.
干预措施: Transplantation of the uterus from live donor. (Procedure)
结局指标
主要结局
transplant sucess rate
时间窗: 2 years after transplantation
Assessed by records from Barretos Cancer Hospital
次要结局
- Pregnancy rate(2 years after transplantation)
- Live births after uterus transplantion(2 years after transplantation)