Non-operative Management for Appendicitis in Children

Status Recruiting

Clinical Trial Summary

This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

Clinical Trial Description

Appendicectomy for acute appendicitis is one of the most commonly performed paediatric emergency operations in Australia. This standard treatment of acute uncomplicated appendicitis (AUA) has remained largely unchallenged since its introduction in the late nineteenth century, under the assumption that AUA progresses to perforation and thus complications should an operation be withheld. However, appendicectomy via laparoscopic or open approach is not without its risks.

Non-operative management (NOM) with antibiotics has been increasingly accepted as mainstay therapy for many intra-abdominal infections. In fact, children with appendicitis complicated by perforation, abscess or phlegmon formation are often preferentially treated non-operatively with antibiotic therapy, with or without percutaneous drainage. Systematic reviews and meta-analyses have demonstrated that antibiotics are a safe and effective treatment for AUA in adults and there is growing evidence that NOM is safe and effective in children.

Primary objectives:

To determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed likely AUA in children.

Secondary objectives:

1. To compare the safety and efficacy of NOM of clinically diagnosed likely AUA with operative management (OM) in children.

2. To assess the cost-effectiveness of NOM of clinically diagnosed likely AUA against OM in children.

3. To assess the feasibility and acceptability of NOM of appendicitis in children.

This study will enrol 226 patients, age 5-16 years, with acute uncomplicated appendicitis at two tertiary children's hospitals. Allocation ratio of 1:1 will be made via weighted minimisation using the following criteria: age (5-8 years or 9-16 years), gender (male or female), and duration of symptoms (<48 or >48 hours). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02795793
Study type	Interventional
Source	Sydney Children's Hospitals Network
Contact	Susan Adams, MBBS
Phone	61 02 9382 1776
Email	susan.adams@unsw.edu.au
Status	Recruiting
Phase	N/A
Start date	May 2016
Completion date	December 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04529980` - Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis	N/A
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Recruiting	`NCT03522233` - Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
Recruiting	`NCT03380793` - A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis	Phase 4
Recruiting	`NCT02108340` - Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis	N/A
Terminated	`NCT02029781` - The Laparoscopic Appendicitis Score; a Multicenter Validation Study	N/A
Completed	`NCT01356641` - Antibiotic Treatment Alone for Acute Simple Appendicitis in Children	N/A
Completed	`NCT01515293` - Single Incision Versus Conventional Laparoscopic Appendectomy	Phase 3
Terminated	`NCT00971438` - Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging	N/A
Completed	`NCT00913380` - Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT	Phase 3
Completed	`NCT00616616` - Single Incision Laparoscopy	N/A
Completed	`NCT00530998` - Minimally Invasive Surgery: Using Natural Orfices
Completed	`NCT00195351` - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection	Phase 4
Completed	`NCT02916134` - Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis	N/A
Completed	`NCT04614649` - Right Iliac Fossa Treatment-Turkey Audit
Completed	`NCT04365491` - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
Completed	`NCT03770897` - Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome	N/A
Completed	`NCT02507674` - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting	`NCT01718275` - Non-operative Management of Early Appendicitis in Children
Terminated	`NCT01575028` - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Non-operative Management for Appendicitis in Children — APRES

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms