A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis
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
the group who was subjected to the reverse conversion technique
干预措施: reverse conversion technique (Procedure)
group B
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
Mohamed lotfy
Associate professor
Zagazig University
