Conservative treatment with antibiotics versus emergency appendectomy for management of acute nonperforated appendicitis in children: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- The feasibility and safety of the Conservative Management (CMx) with Antibiotics in children with acute Nonperforated Appendicitis.
研究概览
简要总结
Although non-operative treatment for uncomplicated appendicitis is now an accepted approach, there are few reports in children. The major advantage of antibiotic treatment is the avoidance of surgery and its complications; the potential disadvantage is the fact that, by not removing inflamed appendix, parents will be concerned about recurrent appendicitis every time a child develops abdominal pain in the future. Data on conservative treatment of nonperforated appendicitis in children are scanty. Few retrospective study published had unclear diagnostic and treatment criteria. Of note, there have been no randomized controlled trials investigating the nonoperative treatment of acute appendicitis in children.
The current study is a randomized controlled trial to evaluate the feasibility and safety of conservative management with antibiotics alone (CMx group) and to compare with the results of emergency surgery (SMx group) in children with acute nonperforated appendicitis admitted to our hospital for a period of 1 year. We plan to enroll 106 children by non probability consecutive sampling method. Each patient will be assigned with a serial number according to their time and date (sequence) of hospitalization. Based on the computer generated table of random numbers with sealed envelope technique they will be randomized into either CMx group or SMx group as per their serial number. Emergency Laparoscopic appendectomy will be done in the SMx group as per Institute protocol. Intravenous broad spectrum antibiotics (Ceftriaxone, Amikacin and Metronidazole) and bowel rest (IV fluids, nil by mouth) will be given in CMx group till the amelioration of symptoms and signs and corroboration with laboratory test (markers of inflammation). They will be discharged with oral antibiotic for 5 days. If there will be any deterioration in clinical condition then emergency surgery will be done in those patients. Follow up at 1 month, 3month and 1 year will be undertaken to assess the feasibility, safety and recurrence rate in the conservative management (CMx) approach and to compare the incidences of significant complications between both the modalities of management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 3 to 14 years both male and female.
- •2.Symptoms of Pain Abdomen, Anorexia, Nausea, Vomiting, Fever.
- •3.Signs of Focal Peritonitis (Guarding, Rebound tenderness) in Right Iliac Fossa (RIF).
- •4.Laboratory Findings of ↑ Total Leukocyte Count, ↑ Neutrophil count, ↑ CRP, ↑ LRG.
- •5.Abdominal Ultrasonogram s/o noncompressible nonperistaltic tubular structure ≥ 6 mm in AP diameter in RIF, probe tenderness in RIF, hyperechoic pericaecal fat & free fluid.
- •6.Abdominal CT scan suggestive of acute nonperforated appendicitis.
排除标准
- •1.History of Recurrent Appendicitis 2.History of Chronic , Intermittent abdominal pain 3.Diffuse abdominal tenderness on clinical evaluation 4.Generalized Septicemia , Other Systemic illnesses 5.Abdominal Ultrasonography s/o Appendicolith, Appendicular Perforation ,Periappendicular Abscess or Phlegmon , Pan-peritonitis.
结局指标
主要结局
The feasibility and safety of the Conservative Management (CMx) with Antibiotics in children with acute Nonperforated Appendicitis.
时间窗: 1st Month - Feasibility assessment | 6th Month - Mid-recruitment review | 1 year - Final assessment.
次要结局
- a)Length of Stay in the Hospital(b)Cost of Treatment)