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临床试验/NCT04094480
NCT04094480Unknown不适用

A Comparison Between Non Absorbable Polymeric Clips and Endoloop Ligatures in Securing Appendicular Stump in Laparoscopic Appendicectomy at Assiut University Hospital

Assiut University0 个研究点目标入组 40 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Operative time

研究概览

简要总结

a) Compare between Nonabsorbable Polymeric Clips and Endoloop ligatures regarding:

  1. technical difficulties.
  2. operation time.
  3. cost effectiveness.
  4. postoperative complications.
  5. inpatient stay.

详细描述

Laparoscopic appendectomy is gradually evolving as the 'gold standard' in the treatment of acute appendicitis, especially in the obese, elderly, and in cases where the diagnosis is uncertain . There are clear benefits with the laparoscopic approach in terms of decreased pain and faster recovery than the open approach . However, disadvantages like a higher incidence of intra-abdominal collection, longer operating time, and higher costs have been documented. These may be dependent on the technique of appendicular stump closure. Therefore, the technique for appendiceal stump closure is crucial in laparoscopic appendectomy.

Laparoscopic appendectomy was first described by Semm in 1983 and is currently preferred approach for an appendectomy for many surgeons. Numerous methods of stump closure have been used, like intracorporeal suturing of the stump endoloop application, endostapler application LigaSure customized titanium clip application, and, more recently, using nonabsorbable plastic clips . Many of these techniques are either time consuming or expensive, or not available universally.

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
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •. Able to give informed consent for inclusion in the study
  • •Age of the patient : Any age

排除标准

  • •• Intraoperative decision to convert to open appendicectomy
  • •Primary open appendicectomy
  • •Unable to give informed consent for participation in the study

研究组 & 干预措施

endoloop ligation

Active Comparator

securing appendicular base with endoloops

干预措施: endoloops (Other)

non absorbable polymeric clips

Active Comparator

securing appendicular base with non absorbable polymeric clips

干预措施: polymeric non absorbable clips (Device)

结局指标

主要结局

Operative time

时间窗: intraoperative

Is there difference in the overall operating time between the two cohorts

次要结局

  • Length of hospital stay (postoperative)(Up to 14 days)
  • Complications(30 days)
  • Time of Application(120 min)
  • Readmission to hospital(30 days)

研究者

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

Mohamed ashraf mohamed badr bestawy

resident doctor

Assiut University

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