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临床试验/NCT05283733
NCT05283733已完成不适用

A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis

Zagazig University1 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2018年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
426
试验地点
1
主要终点
rates of wound infection

研究概览

简要总结

A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis

详细描述

Introduction

Acute appendicitis (AA), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. The surgical approach to AA is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. The goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. Patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group A (interventional) 213 patients who were subjected to the reverse conversion technique and group B (control)213 patients who were operated by the open technique. The key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. The hospital length of stay and the operative time were used as secondary end goals for comparison.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •symptoms consistent with acute perforated appendicitis,
  • •had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,
  • •ages ranging from 16 to 65 years.

排除标准

  • •radiological evidence of appendicular mass,
  • •septic shock or multi-organ failure (MOF) at presentation,
  • •Diabetes Mellitus (DM), renal failure, morbid obesity
  • •recent (6-month) history of thromboembolic disease
  • •immunomodulators,
  • •a history of inflammatory bowel disease (IBD),
  • •postoperative pathological report of the removed appendix revealed carcinoid or Crohn's disease,
  • •American Society of Anesthesiology (ASA) classification more than II.

研究组 & 干预措施

group A

Experimental

the group who was subjected to the reverse conversion technique

干预措施: reverse conversion technique (Procedure)

group B

No Intervention

the control group who was completed by open technique

结局指标

主要结局

rates of wound infection

时间窗: 3 months post operative

rates of complications

the rates of intraabdominal abscess

时间窗: 3 months post operative

rates of complications

rates of ileus

时间窗: Baseline (Hospital admission)

rates of reoperation

时间窗: 3 months post operative

次要结局

  • the operative time(Intraoperative)
  • The hospital length of stay(up to 3 months)

研究者

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

Mohamed lotfy

Associate professor

Zagazig University

研究点 (1)

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