NCT01697059

Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Completed NA Last updated 4 May 2015

What this trial tests

NA trial testing Piperacillin + Amoxicillin in Acute Appendicitis in 73 participants. Completed in 1 May 2015.

Timeline

1 September 2012

Primary endpoint
1 May 2015

1 May 2015

Quick facts

Lead sponsor	Rhode Island Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	1 September 2012
Primary completion	1 May 2015
Estimated completion	1 May 2015
Sites	1 location across United States

Drugs / interventions tested

• Piperacillin + Amoxicillin — full drug profile →

Conditions studied

• Acute Appendicitis — all drugs for Acute Appendicitis →

Sponsor

Rhode Island Hospital

Who can join

Adults 5 to 18, any sex, with Acute Appendicitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of treatment failures
  Time frame: Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment
  If after a period of at least 8 hours (and 2 doses of intravenous antibiotics), the patient's symptoms worsen, or fail to subside within 18 hours, the patient will undergo an emergent/urgent appendectomy, and treatment will proceed as per standard-of-care (1 intraoperative dose of antibiotics, with or without postoperative antibiotics, progressive postoperative diet and discharge home once tolerat

Sponsor's own description

Several recent studies have examined the feasibility and benefits of nonoperative treatment of perforated appendicitis in children. One such study showed a trend toward longer operative times for patients randomized to immediate appendectomy, but no overall advantage. In another larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other studies have demonstrated the safety of delaying appendectomy for perforated appendicitis.

Emergency appendectomy is a well-established approach, and postoperative recovery in children is fast. Nevertheless, from the onset of symptoms through the hospital stay and the postoperative recovery, appendicitis causes a disruption of a family's normal routine (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation, patients have to wait until an operating room becomes available, or elective operations have to be placed on hold to accommodate the emergency operation. Each year, more than 250 children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery, or about one emergency add-on operation per working day. If an initial trial of antibiotics is safe for the treatment of appendicitis, converting an emergency operation into an elective, scheduled outpatient procedure may reduce stress and disruption of routine for patients and their families - and may allow better operating room planning for health care professionals and hospitals.

The investigators hypothesize that initial antibiotic treatment of acute (non-perforated) appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of treating the disease and results in greater patient and family satisfaction.

This pilot study aims to establish the safety and feasibility of treating acute appendicitis with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and their families will be offered the possibility of initial nonoperative treatment and subsequent outpatient elective appendectomy in a nonrandomized, single arm study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Publication status of completed registered studies in paediatric appendicitis: a cross-sectional analysis.
   Breil T, Boettcher M, Hoffmann GF, Ries M. · · 2018 · cited 7× · PMID 30012791 · DOI 10.1136/bmjopen-2018-021684