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临床试验/NCT02673528
NCT02673528已完成不适用

Laparoscopic Assisted or Total Laparoscopic Appendectomy in Patients With Uncomplicated Acute Appendicitis: a Matched Case-control, Cost-utility Study

Medical Park Gaziantep Hospital0 个研究点目标入组 451 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
451
主要终点
A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale)

研究概览

简要总结

Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy.

Following laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported.

The authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost.

详细描述

Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy. Until the first laparoscopic removal of an inflamed appendix by Kurt Semm in 1980, the gold standard for surgical treatment of acute appendicitis remained open appendectomy as first described by McBurney in 1891.

At the beginning, LA remained questionable whether the benefits of the procedure outweigh over its disadvantages. However, since laparoscopic technology advances and surgeons' expertise increases, many surgeons have successfully performed a multitude of laparoscopic procedures for AA, with a continued increasing trend in its use. Eventually, after LA proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance.

There are more techniques for LA in the literature but only a few of them have gained to access and described in modern textbooks. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported which include two-port techniques, single-port techniques, and hybrid approaches. The two-port appendectomy technique consist of one port providing access for a rigid telescope with a working channel, and second port for a grasping forceps that is used to retract the appendix. In the single-port assisted technique, after a stitch is placed between the appendix and the anterior abdominal wall to pull the appendix and create a tension to facilitate dissection, and then appendectomy is performed intracorporeally. The hybrid technique formed from the combination of both open and laparoscopic approaches. Namely the appendix is pulled out through the only or one of the port, and a traditional open appendectomy is then performed extracorporeally.

The authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients using Euro Qol (EQ) - 5 Dimensions (5D) - 3 Levels (3L) (EQ-5D-3L) and Visual Analogue Scale (VAS) and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost. For these purposes, a case-control study was designed in January 2015 to investigate these issues.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all acute appendicitis patients underwent total laparoscopic appendectomy or laparoscopic assisted appendectomy

排除标准

  • no written informed consent

结局指标

主要结局

A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale)

时间窗: two times: 7th and 14th day after the surgery

visual analogue scale of health related evaluation

Calculation of Cost utility

时间窗: within 1 month after surgery

depends on the calculation of hospital based costs and QALY

A weekly change in EQ-5D-3L scores (Euro Qol 5 dimensions 3 levels)

时间窗: two times: 7th and 14th day after the surgery

health related evaluation

次要结局

  • Ratio of conversion to TLA(within the first month after completion of the patient recruitment)
  • The rate of the location of appendix(within 1 month after completion of the patient recruitment)
  • Mean BMI of patients in the groups(within 1 month after completion of the patient recruitment)

研究者

发起方
Medical Park Gaziantep Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Kaplan

Head of General Surgery

Medical Park Gaziantep Hospital

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