Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study
研究概览
详细说明
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.
The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.
The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).
The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.
At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.
At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Clermont-Ferrand、法国、63003
- 招聘中
- CHU de Clermont-Ferrand
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：standard instrument
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
|
|
其他：less than 3 millimeter diameter's instruments
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
operative time
大体时间：at day 1 (at the end of the surgery)
|
at day 1 (at the end of the surgery)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
quantity of intraoperative bleeding
大体时间：at day 1 (at the end of the intervention)
|
at day 1 (at the end of the intervention)
|
|
|
hemoglobin
大体时间：at day 1
|
at day 1
|
|
|
Pain Rating Scale (VAS)
大体时间：at day 1 (at 6 hours potoperative hours)
|
at day 1 (at 6 hours potoperative hours)
|
|
|
Pain Rating Scale (VAS)
大体时间：at day 1 (at 24 postoperative hours)
|
at day 1 (at 24 postoperative hours)
|
|
|
standard laparoscopy conversion rate
大体时间：at day 1
|
at day 1
|
|
|
postoperative complications
大体时间：at each additional hospitalisation
|
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
|
at each additional hospitalisation
|
|
Patient Scar Assessment Scale (PSAS)
大体时间：at 6 and 8 weeks after surgery.
|
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
|
at 6 and 8 weeks after surgery.
|
|
Surgen's ergonomics
大体时间：at the end of the surgery
|
Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
|
at the end of the surgery
|
合作者和调查者
调查人员
- 首席研究员：Revaz BOTCHORISHVILI、CHU de Clermont-Ferrand
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CHU-0223
- 2014-A01698-39 (其他标识符：ANSM)
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