Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy
Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
研究概览
详细说明
This prospective randomized controlled trial was planned to be conducted from February 2020 to February 2021 and included total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during the study period.
Surgeries on patients with existing comorbidity, with underlying malignant conditions, patients diagnosed deeply infiltrative endometriosis during surgery and patients who undergo multiple surgeries will be excluded from the study.
Clinical and descriptive data will be collected from both paper and electronic records, including the pain of the patient, the need for analgesia at the 6th-12th and 24th hour during the post-operative period. Visual analog scale (VAS) will be used to track the pain progression of the patients. Intraabdominal bleeding will be determined by measuring the hematocrit levels and drainage volume at postoperative day 1. Patients will also be assessed according to manifesting an infection in both the short term and long term.
Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Data will be analyzed using the Statistical Package for Social Sciences (SPSS). A Chi-squared test will be used to evaluate the significance of the associations between variables. Continuous variables will be displayed as means and standard deviations. A P value of ≤0.050 will be considered as significant.
This study obtained ethical approval from the Medical Research & Ethics Committee of Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Istanbul、火鸡
- 招聘中
- Zeynep Kamil
-
接触：
- enis ozkaya, md
- 电话号码：0090 5054742459
- 邮箱：enokaya1979@gmail.com
-
Istanbul、火鸡
- 招聘中
- Zeynep Kamil Maternity and Children Training and Research Hospital
-
接触：
- enis ozkaya, associated professor
- 电话号码：0090 216 334 94 00
- 邮箱：istzeynepkeah.hhak@saglik.gov.tr
-
-
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:
- Female
- age between 40-70
- undergoing surgery for a benign condition
- having an abdominal surgery for the first time
Exclusion Criteria:
- existing comorbidity
- with underlying malignant conditions
- patients diagnosed deeply infiltrative endometriosis during surgery
- patients who undergone multiple surgeries
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：CONTROL GROUP
patients without a drain
|
|
|
实验性的：CASE GROUP
Patients a drain inserted
|
A surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
analgesia need at the post-operative period
大体时间：post operative 6. hour
|
patient need for analgesia during post operative first day
|
post operative 6. hour
|
|
hematocrit levels
大体时间：post operative first day
|
patient hematocrit level at post operative day 1
|
post operative first day
|
|
drainage volume
大体时间：post operative first day
|
drainage volume at postoperative day
|
post operative first day
|
|
post operative infection
大体时间：post operative first day and post operative 1. week
|
manifesting an post operative infection in short term and long term
|
post operative first day and post operative 1. week
|
|
pain post operative 6.-12. and 24. hour
大体时间：pain
|
will be measured using VAS score
|
pain
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
analgesia need at the post-operative 6. hour
大体时间：post-operative 6. hour
|
patient need for analgesia
|
post-operative 6. hour
|
|
analgesia need at the post-operative 12. hour
大体时间：post-operative 12. hour
|
patient need for analgesia
|
post-operative 12. hour
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.