Non Operative Treatment With Antibiotics Vs Surgery for Acute Non Perforated Appendicitis in Children: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Food Tolerance
研究概览
简要总结
Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is curative but it is an invasive procedure done under general anesthesia with different risks and complications during and after operation, leading to disturbance of child daily routines and activities. Reported rates of perioperative complications are from 5% - 10%, with serious complications occurring in 1% to 7% of patients.
Children presenting with acute (<2 days) right iliac fossa pain with pediatric appendicitis score >7, with none of the following on ultrasonography: abscess formation, or loss of the echogenic sub-mucosal layer of the appendix or presence of an appendicolith or periappendiceal fluid collection will be labeled as having appendicitis.
After diagnosis we divided the patients into two groups.patients in group A will be treated with antibiotics and appendectomy is done for group B patients.
详细描述
Acute appendicitis is one of the most common presenting conditions in pediatric emergencies. It has an estimated lifetime risk of about 8%. Although it commonly occurs in the second decade of life but 11.4% children are diagnosed with acute appendicitis in the pediatric emergency.
The rationale of my study is that limited local clinical trial is available regarding the efficacy of non-operative treatment with antibiotics vs operative treatment of acute non-perforated appendicitis in children.
All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having pediatric appendicitis score (PAS anexure 1) >7 will be included in the study.
All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Each patient will be evaluated and relevant data according to the predesigned questionnaire will be collected and documented. Age, duration of symptoms, body temperature,C-reactive protein, white blood cell, neutrophil concentrations, Ultrasound findings and PAS score will be noted at the time of admission. Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day divided into 2 divided doses) and metronidazole (20 mg/kg × 1 per 24 hours) for another 8 days. Supportive care will be given equally to all the patients as protocol of treatment with regular vital monitoring. Improvement or development of complications will be noted. Discharge criteria for both groups will be: afebrile for 24 hours, with or without oral antibiotics, adequate pain relief on oral analgesia assesd by visual analogue scale ( VAS) scale (anexure 2), tolerating a light diet, and mobile.
Failure of non-operative treatment will be defined if any one of the following is seen: abscess formation or complex peri-appendiceal fluid collection seen on ultrasonography, the need for surgery (due to worsening of symptoms evaulated by history, physical examination and repeat ultrasonography) within 48 hours, or recurrence of appendicitis within 3 months.
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
盲法说明
The individual who evaluates the outcome(s) of interest
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having PAS score >7will be included in the study.
排除标准
- •Patient with suspicion of perforated appendicitis on the basis of generalized peritonitis and abscess formation on ultrasound.
- •Patients with an appendicular mass, diagnosed by clinical examination and ultrasonography.
- •Patient with previous non-operative treatment of acute appendicitis (recurrent appendicitis)
- •Patients with C-reactive proteins > 40 mg/L.
- •Patients with history of any previous abdominal surgery.
研究组 & 干预措施
Meronem and flagyl
Children in Non-operative treatment (group A) Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day) divided into 2 divided doses) and metronidazole (20 mg/kg/day divided into 3 doses for another 8 days.
干预措施: Meronem and flagyl (Drug)
Surgery (appendectomy)
Children in group B: appendectomy will b done and post operative single dose of antibiotics.
discharge after 24hour and Follow up after 1 week.
干预措施: Appendectomy (Procedure)
结局指标
主要结局
Food Tolerance
时间窗: 24 hour
Child starts oral intake and had no symptoms after food intake.
Afebrile
时间窗: 24 hours
Temperature less than 98 Fahrenheit.
Pain relief
时间窗: 24 hour
Pain relief assessed by visual analogue scale (VAS) score \< 3
次要结局
- Recurrence of symptoms of acute appendicitis(Within 3 months.)
研究者
Fatima Numeri
Assistant Professor
King Edward Medical University