Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- analgesia need at the post-operative period
研究概览
简要总结
This prospective randomized controlled trial was planned to be conducted among total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during one year period. The effect of drain insertion during the surgery will be assessed by this clinical trial. Patients will be assigned into two groups as cases and controls. Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Patients will be evaluated according to their post operative VAS scores, hematocrit levels, their drainage volume and manifestation of an infection after the surgery.
详细描述
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 40-70
- •undergoing surgery for a benign condition
- •having an abdominal surgery for the first time
排除标准
- •existing comorbidity
- •with underlying malignant conditions
- •patients diagnosed deeply infiltrative endometriosis during surgery
- •patients who undergone multiple surgeries
结局指标
主要结局
analgesia need at the post-operative period
时间窗: post operative 6. hour
patient need for analgesia during post operative first day
drainage volume
时间窗: post operative first day
drainage volume at postoperative day
hematocrit levels
时间窗: post operative first day
patient hematocrit level at post operative day 1
post operative infection
时间窗: post operative first day and post operative 1. week
manifesting an post operative infection in short term and long term
pain post operative 6.-12. and 24. hour
时间窗: pain
will be measured using VAS score
次要结局
- analgesia need at the post-operative 6. hour(post-operative 6. hour)
- analgesia need at the post-operative 12. hour(post-operative 12. hour)
研究者
enis ozkaya
ASSOCIATED PROFESSOR
Zeynep Kamil Maternity and Pediatric Research and Training Hospital