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临床试验/NCT05528003
NCT05528003已完成不适用

Comparison of Homemade Versus Commercialized Single-access Port Devices for Single-incision Laparoscopic Appendectomy: A Retrospective Comparative Study

National Taiwan University Hospital0 个研究点目标入组 161 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
主要终点
Deep/organ SSI

研究概览

简要总结

Homemade and commercialized single-assess port devices are two kinds of port devices commonly used for single-incision laparoscopic appendectomy. This study aimed to compare these two port devices in terms of short-term surgical outcomes and medical costs.

详细描述

The advantages of homemade port devices include accessibility of the composites and lower equipment costs to the patients; however, the potential disadvantage is the easy leakage of CO2, ballooning of the surgical glove, and device instability, leading to difficult maneuverability. On the other hand, commercialized port devices have relatively easy maneuverability, flexibility for instrument changes, and port stability for long-duration surgery ; however, their higher equipment cost is a disadvantage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients were diagnosed as acute appendicitis and undergoing single-incision laparoscopic appendectomy

排除标准

  • The patient was not diagnosed as acute appendicitis based on surgical finding or pathological findings
  • The patients underwent surgery other than single-incision laparoscopic surgery

结局指标

主要结局

Deep/organ SSI

时间窗: Complications happened within 30 days

SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification

Total surgical complications

时间窗: Complications happened within 30 days

Complications were defined by Clavien-Dindo classification and comprehensive complication index.

Superficial incisional surgical site infection (SSI)

时间窗: Complications happened within 30 days

SSI was defined according to the American Centers for Disease Control and Prevention (CDC) classification

Postoperative ileus

时间窗: Complications happened within 30 days

Postoperative ileus was defined as the presence of symptoms and signs of abdominal distention, nausea, or vomiting combined with abdominal radiography, such as plain radiography or CT, within 30 days after SILA.

次要结局

  • Surgical time(Time from skin incision to application of gauzes)
  • Total medical costs(From the time patient being brought to emergency room to the time patient being discharged)
  • Postoperative length of hospitalization(Postoperative LOH was defined as the duration between leaving the recovery room and discharge.)
  • Time to resume soft diet(The time to resume a soft diet was measured as the duration between the time leaving the recovery room and the time to resume a soft diet recorded in the nursing note.)

研究者

申办方类型
Other
责任方
Sponsor

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