Lateral Versus Cervical Coagulation of the Uterine Artery in Benign Hysterectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Frequency of postoperative hematoma
研究概览
简要总结
Laparoscopic hysterectomy is associated with complications in form of infections and subsequently dehiscence of the vault. This is a serious complication. The infection may be related to the frequently observed postoperative hematoma following traditional laparoscopic hysterectomy where the uterine artery is coagulated and divided at the cervical entry into the uterus.
By coagulation of the uterine artery laterally close to the internal iliac artery this problem may be eliminated due to the much less bleeding observed during this procedure.
详细描述
Laparoscopic hysterectomy (removal of the uterus) is today a well-described method for the removal of the uterus. The operation is offered in case of bleeding disorders where other treatments have been unsuccessful, uterine fibroids or other conditions requiring surgery with removal of the uterus.
The operation is done today in most cases by dividing the uterine artery at the entrance to the cervix, where the artery divides into one ascending and descending branch.
The most common complication of hysterectomy is bleeding perioperative well as postoperatively, which may result in a hematoma above the vaginal vault.
Through the years different methods have been tried to reduce this complication, including tranexamic acid without great success. The hematoma may result in infection postoperative and subsequent poor healing, with the possibility of dehiscence of the vault.
In the worst case, the gut is displaced through the vagina postoperatively. This condition can lead to diffuse peritonitis, which can be fatal in rare cases.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women submitted to total laparoscopic hysterectomy
排除标准
- •Women <18 years
- •Women no able to understand the study or not native in Danish
- •Women with uterine malignancy
- •Women with suspicion of pelvic mass
- •Women with abnormal coagulation
- •Women receiving glucocorticoid treatment
- •Women receiving anticoagulant treatment or have not followed prescription in relation to surgery
研究组 & 干预措施
cervical occlusion
Women included in this arm is randomized to occlusion of the uterine artery at cervical entry
干预措施: Cervical occlusion (Procedure)
Lateral occlusion
Women included in this arm is randomized to lateral occlusion of the uterine artery
干预措施: Lateral occlusion (Procedure)
结局指标
主要结局
Frequency of postoperative hematoma
时间窗: 2 years
次要结局
未报告次要终点
研究者
Vibeke Lysdal
Consultant
Odense University Hospital