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临床试验/NCT04485247
NCT04485247Unknown不适用

Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?

Myongji Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
78
试验地点
1
主要终点
Operation time

研究概览

简要总结

transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective studies. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

详细描述

Single port appendectomy can be considered as the better option than conventional laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis in cosmetic aspect. However, this technique has not gained popularity because it has been regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric patients with uncomplicated appendicitis. The reason that this operation is possible in children, is that the length between umbilicus and appendix is shorter than that of an adult, and the abdominal wall is flexible, so that the appendix can be extracted through umbilical incision. It was reported that the operation time was shorter and the postoperative frequency of complications was not high compared to the laparoscopic appendectomy with three conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with clinically diagnosed as acute appendicitis
  • •Age 18 or under
  • •Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L
  • •no significant dysfunction in the heart, lungs, kidneys.

排除标准

  • •Previous abdominal operation
  • •Generalized peritonitis
  • •Anticipated extended resection
  • •Periappendiceal abscess on preoperative exam

研究组 & 干预措施

Conventional group

Active Comparator

conventional laparoscopic appendectomy with 3-ports

干预措施: 3-port laparoscopic appendectomy (Procedure)

TULAA group

Experimental

An operator extracts and ligates appendix through umbilical port.

干预措施: Transumbilical Laparoscopic-Assisted Appendectomy (Procedure)

结局指标

主要结局

Operation time

时间窗: 1 day

Time from skin incision to skin closure

次要结局

  • Postoperative complication rate(1 month)
  • postoperative hospital stay(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyung-Goo Lee

Assistant professor

Myongji Hospital

研究点 (1)

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