drugset / Trial / NCT04030741

Non-operative Treatment of Acute Non-perforated Appendicitis

NCT04030741

Phase 2/3 Completed 180 enrolled King Edward Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-09-01
Primary completion
2019-12-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 20 mg/kg Oral
Comparator Meropenem Small molecule 10 mg/kg Intravenous
Comparator Metronidazole Small molecule 20 mg/kg Intravenous

Indications