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临床试验/NCT04083313
NCT04083313已完成不适用

Analysis of Endoloops, Endostaples and Endoclips for Closing the Appendiceal Stump During Laparoscopic Appendectomy

University Hospital Dubrava2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
Operative and postoperative complications

研究概览

简要总结

In this randomized control trial the patients with acute appendicitis will be divided in three groups according to the management of the appendiceal stump(Endostapler, Endoloop or Endoclip). Pre-, peri- and postoperative data will be analysed.

详细描述

Acute appendicitis is the most common indication for intraabdominal emergency surgery, and appendectomy is one of the most commonly performed procedures in abdominal surgery. Today laparoscopic appendectomy (LA) has the status of a ''Gold Standard'' treatment, and it is accepted as the treatment of choice for acute appendicitis.There are several ways of closing the appendiceal stump.An inadequate closure of the appendiceal stump can lead to morbidity of operated patients. The aim of this study is to assess the efficiency of different closure techniques by focusing on the intraoperative and postoperative complications.The patients will be divided into three groups based on the technique used for appendiceal stump closure, whether it is Endoloop, Endostapler or Endoclip. In the patients included in the study the investigators will analyse demographic data, peroperative laboratory values, clinical data and treatment outcomes. Also, the histopathological findings of the specimens and perioperative and postoperative complications will be analysed.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with clinically and radiologically(Ultrasound) verified appendicitis

排除标准

  • Patients converted from laparoscopy to open surgery

结局指标

主要结局

Operative and postoperative complications

时间窗: Seven postoperative days

Number of all complications will be presented in total numbers.

次要结局

  • Height(Before surgery)
  • Weight(Before surgery)
  • Duration of symptoms(Before surgery)
  • Value levels of leukocytes(Before surgery)
  • Neutrophiles(Before surgery)
  • C-reactive protein(Before surgery)
  • Body mass index(Before surgery)
  • Body temperature(Before surgery)
  • Length of the operations(During operation)
  • Number of reoperated patients(Seven days)
  • Hospital stay(Seven days)
  • Histopathological findings(Seven days)
  • Percentage of reoperated patients(Seven days)
  • Closure of the appendiceal stump using Endoloop(During operation)
  • Closure of the appendiceal stump using Endostapler(During operation)
  • Closure of the appendiceal stump using Endoclip(During operation)

研究者

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

Mislav Rakić, MD

Head of the Department of Hepatobilliary surgery

University Hospital Dubrava

研究点 (2)

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