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临床试验/NCT07091110
NCT07091110已完成不适用

Efficacy of LigaSure Versus Harmonic Scalpel US in Laparoscopic Appendectomy in Management of Acute Appendicitis

Zagazig University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
the average range of operating time for both groups

研究概览

简要总结

Background Acute appendicitis is the most frequent abdominal surgical emergency worldwide, peaking in incidence between the second and third decade of life. Appendectomy was the only treatment for appendicitis for more than a century, and it is still the most common treatment. The surgical treatment for appendicitis is an appendectomy, which can be performed laparoscopically or openly. The purpose of the current study is to determine and measure the safety and effectiveness of laparoscopic appendectomy with LigaSure and harmonic US scalpels.

Patients and methods:

This research was carried out from January 2023 to January 2025, involved 60 patients who complained of acute lower abdominal pain in their right side, and were diagnosed with suspected acute appendicitis. Two groups of patients were formed: Group A had an appendectomy performed laparoscopically using a harmonic US scalpel, and group B underwent a laparoscopic appendectomy using LigaSure.

详细描述

Study Design This is a prospective comparative study for a total of 60 patients participated in this study, which ran from January 2023 to January 2025. Patients were complaining of acute right lower abdominal pain, after clinical examination, laboratory and radiological investigations diagnosed as acute appendicitis. Patients were randomized by the closed envelope method into 2 equal groups; 30 patients for each. Group A (laparoscopic appendectomy using harmonic US scalpel and endoloop) and group B (laparoscopic appendectomy using LigaSure plus endoloop).

Study Approval Ethical approval for this study was granted by the Institutional Review Board of the Zagazig University, with an IRB registration number is ZU-IRB#1419/17-6-2025.

Inclusions criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.

Exclusions criteria We excluded patients with complicated acute appendicitis as appendicular mass or abscess, patients with history of previous multiple open abdominal surgeries, patients with economic factors and also patients who preferred conventional, open appendectomy to laparoscopic removal approach.

Examination, diagnosis and Workup protocol The patient's complete medical history (including a typical recent non-neglected right lower abdomen or periumbilical discomfort, nausea/vomiting, anorexia, or a low grade fever, etc.) and physical examination (right iliac fossa tenderness or guarding with a positive Mc-Burney's sign, cough test, etc.) were used to make the clinical diagnosis of non-complicated acute appendicitis. Laboratory tests such as the complete blood count (CBC), C-reactive protein (CRP), pregnancy test for female patients in the childbearing age range, etc., were needed for each patient and interpreted. Additionally, all patients underwent an ultrasound, either with or without a pelvi-abdomen CT scan with contrast, to confirm the diagnosis, rule out other potential causes of acute abdomen, and-most importantly-rule out patients with complicated appendicitis, such as those with phlegmon, generalized peritonitis, or appendicular abscess.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory, and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.

排除标准

  • We excluded patients with complicated acute appendicitis, such as appendicular mass or abscess, patients with a history of previous multiple open abdominal surgeries, patients with economic factors, and also patients who preferred conventional, open appendectomy to the laparoscopic removal approach.

结局指标

主要结局

the average range of operating time for both groups

时间窗: from January 2023 to January 2025

Depending on the degree of difficulties experienced, the average range of operating time for both groups was reported.

次要结局

  • intraoperative complications(from January 2023 to January 2025)
  • conversion to open surgery(from January 2023 to January 2025)
  • postoperative complications(from January 2023 to January 2025)

研究者

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

Mohamed I Farid

assistant professor of general surgery

Zagazig University

研究点 (1)

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