跳至主要内容
临床试验/NCT06177418
NCT06177418招募中不适用

Glove Finger Method to Prevent Wound Infection in Children Undergoing Transumbilical Laparoscopic Appendectomy

Necmi Kadıoğlu Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Postoperative wound infection

研究概览

简要总结

Transumbilical laparoscopic appendectomy (TULA) is increasingly favored in the treatment of appendicitis within the realm of minimally invasive surgical approaches. This procedure offers advantages such as superior cosmetic outcomes and reduced postoperative pain. However, like all surgical interventions, it carries the inherent risk of surgical site infections (SSI), which pose significant challenges to patient health and healthcare systems by escalating treatment costs, prolonging recovery, and increasing morbidity rates. This study aims to evaluate the efficacy of the "glove finger method" in mitigating SSI risk in TULA.

The rationale for this study is predicated on the hypothesis that the glove finger method could serve as a simple and cost-effective measure offering potential protection against SSIs. When compared to traditional methods, this technique may not only reduce surgical duration but also diminish the risk of SSIs, thereby potentially decreasing hospital stay durations. Furthermore, enhancing the understanding of factors contributing to the development of SSIs and developing effective strategies for their prevention can elevate patient care quality and alleviate the burden on healthcare systems.

详细描述

Transumbilical laparoscopic appendectomy (TULA) is increasingly favored in the treatment of appendicitis within the realm of minimally invasive surgical approaches. This procedure offers advantages such as superior cosmetic outcomes and reduced postoperative pain. However, like all surgical interventions, it carries the inherent risk of surgical site infections (SSI), which pose significant challenges to patient health and healthcare systems by escalating treatment costs, prolonging recovery, and increasing morbidity rates. This study aims to evaluate the efficacy of the "glove finger method" in mitigating SSI risk in TULA.

The rationale for this study is predicated on the hypothesis that the glove finger method could serve as a simple and cost-effective measure offering potential protection against SSIs. When compared to traditional methods, this technique may not only reduce surgical duration but also diminish the risk of SSIs, thereby potentially decreasing hospital stay durations. Furthermore, enhancing the understanding of factors contributing to the development of SSIs and developing effective strategies for their prevention can elevate patient care quality and alleviate the burden on healthcare systems.

This study will compare transumbilical laparoscopic appendectomy (TULA) methods applied to pediatric patients diagnosed with acute appendicitis at our clinic. Employing a randomized controlled design, the study aims to assess the efficacy and safety differences between two distinct surgical techniques currently in practice.

The study will adopt a randomized, controlled, and prospective design. Patients will be randomly allocated into two groups based on the treatment methods:

Group 1: Standard TULA Group: In this group, patients will undergo the standard TULA procedure through a 15 mm trocar port in the umbilical region. The procedure will involve locating the appendix and removing it via an extracorporeal approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients undergo appendectomy between 5 and 18 years.

排除标准

  • •Comorbidity previous surgery

研究组 & 干预措施

Standard transumbilical laparoscopic appendectomy

Active Comparator

In this group, patients will undergo the standard transumbilical laparoscopic appendectomy procedure through a 15 mm trocar port in the umbilical region. The procedure will involve locating the appendix and removing it via an extracorporeal approach.

干预措施: Standard transumbilical laparoscopic appendectomy (Procedure)

Transumbilical laparoscopic appendectomy + glove finger technique

Experimental

In addition to the standard transumbilical laparoscopic appendectomy procedure, patients in this group will receive the glove finger technique, aimed at preventing contamination of surrounding tissues by infected tissue.

干预措施: Transumbilical laparoscopic appendectomy + Glove finger technique (Procedure)

结局指标

主要结局

Postoperative wound infection

时间窗: 2 weeks

Postoperative wound infection

Operative time

时间窗: intraopertaive period

operative time

次要结局

未报告次要终点

研究者

发起方
Necmi Kadıoğlu Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Azizoğlu

Medical Doctor, Necmi Kadıoğlu Hospital

Necmi Kadıoğlu Hospital

研究点 (1)

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