Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
2011年6月21日 更新者：The Second People's Hospital of GuangDong Province
Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
The role of laparoscopic surgery in pediatric inguinal hernia repair is clear.
Laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury.
However, the problem of recurrent rate has not been resolved.
The aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (LIH) repair in children.
The investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication
研究概览
地位
完全的
条件
详细说明
The primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction.
The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.
The cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9).
The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3).
The long axis of the testes was measured.
研究类型
观察性的
注册 (实际的)
575
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Guangdong
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GuangZhou、Guangdong、中国、510317
- The Second People's Hospital of Guangdong Province
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 17年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
All patients between 2 years and 17 years of age undergoing laparoscopic inguinal hernia repair at our institution by a single surgeon from January, 2000 to August, 2005 were prospectively followed for outcome.
描述
Inclusion Criteria:
- unilateral inguinal hernia
- age between 2 years and 17 years
- no history of abdominal or inguinal operations
- the age range was based on the day surgery criteria of our hospital
- of male patients, only those with completely descended testes were included
Exclusion Criteria:
- the bilateral hernia
- the recurrence hernia
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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group A
the patients were accepted laparoscopic purse-string knot closing the internal hernia opening only
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group B
the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot
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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 |
|---|---|---|
|
recurrence rate
大体时间：five years
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the inguinal hernia recurrence after operation
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five years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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number of days to recovery normal activity
大体时间：one month
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the days to recovery normal activity after surgery
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one month
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degree of postoperative pain
大体时间：one year
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postoperative pain was recorded on a modified objective pain scale (OPS) from 0 to 9.9.
The next morning following discharge, a nurse specialist blinded to the operative approach phoned the families and recorded the level of pain on a scale from 0 to 3 (no pain = 0, mild pain = 1, moderate pain = 2, severe pain = 3)
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one year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：kaiyun chen, MD、The Second People's Hospital of Guangdong Province
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2000年1月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2010年9月2日
首先提交符合 QC 标准的
2011年6月20日
首次发布 (估计)
2011年6月21日
研究记录更新
最后更新发布 (估计)
2011年6月22日
上次提交的符合 QC 标准的更新
2011年6月21日
最后验证
2000年1月1日
更多信息
与本研究相关的术语
其他研究编号
- ABT-1233-RV
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