Comparative Study on the Effect of Uterine Round Ligament Preservation Vs Resection in Laparoscopic Inguinal Hernia Repair in Women： a Multicenter,Stratified Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Time required for patient surgery
研究概览
简要总结
This study aims to compare the clinical effects of uterine round ligament preservation versus resection in laparoscopic inguinal hernia repair in women.The primary outcomes included Time required for patient surgery.The secondary outcomes included Inguinal hernia recurrence,quality of life assessment,Indicators of postoperative recovery,, et al.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •►Age : Female patients over 18 years of age without a childbearing requirement
- •Diagnosis and basis : Female patients diagnosed with Unilateral inguinal hernia.
- •agreed to participate in this study and signed the informed consent form.
排除标准
- •►Combined with severe heart, liver, kidney and other diseases.
- •pregnant or lactating women.
- •those with surgical contraindications.
研究组 & 干预措施
Patients with unilateral hernia who did not give birth,the uterine round ligament resection group
Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who did not give birth)
干预措施: To remove the uterine uterine ligament (Procedure)
Patients with unilateral hernia who did not give birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who did not give birth)
Patients with unilateral hernia who have given birth,the uterine round ligament resection group
Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who have given birth)
干预措施: To remove the uterine uterine ligament (Procedure)
Patients with unilateral hernia who have given birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who have given birth)
Patients with bilateral hernias who have given birth,the uterine round ligament resection group
Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernias who have given birth)
干预措施: To remove the uterine uterine ligament (Procedure)
Patients with bilateral hernias who have given birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernias who have given birth)
Patients with bilateral hernia who did not give birth,the uterine round ligament resection group
Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernia who did not give birth)
干预措施: To remove the uterine uterine ligament (Procedure)
Patients with bilateral hernia who did not give birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernia who did not give birth)
结局指标
主要结局
Time required for patient surgery
时间窗: 20-120minutes
Time required for patient surgery
次要结局
- Inguinal hernia recurrence(1 month, 3 months, 6 months,1year,2years,3years,6years)
- Quality of life assessment(3 months,6months,1year,2years,3years,6years)