Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Acute Appendicitis Clinical Trial

Official title:

Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697059
• Other study ID #: RIH408212
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: May 4, 2015
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Maximum 48-hour-history of abdominal pain

• Diagnosis of acute appendicitis based on clinical, laboratory and/or radiologic criteria

Exclusion Criteria:

• Duration of symptoms > 48 hours

• Presence of an appendiceal abscess on imaging

• Clinical or laboratory suspicion of advanced appendicitis, peritonitis or perforation

• Significant comorbidities

• Inability or unwillingness to complete a 1-week course of oral antibiotics

• Allergy to penicillin

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Appendicitis

Intervention

Drug:
• Piperacillin + Amoxicillin

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital (Rhode Island Hospital)	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Narsule CK, Kahle EJ, Kim DS, Anderson AC, Luks FI. Effect of delay in presentation on rate of perforation in children with appendicitis. Am J Emerg Med. 2011 Oct;29(8):890-3. doi: 10.1016/j.ajem.2010.04.005. Epub 2010 Jul 13. — View Citation

Powers RJ, Andrassy RJ, Brennan LP, Weitzman JJ. Alternate approach to the management of acute perforating appendicitis in children. Surg Gynecol Obstet. 1981 Apr;152(4):473-5. — View Citation

St Peter SD, Aguayo P, Fraser JD, Keckler SJ, Sharp SW, Leys CM, Murphy JP, Snyder CL, Sharp RJ, Andrews WS, Holcomb GW 3rd, Ostlie DJ. Initial laparoscopic appendectomy versus initial nonoperative management and interval appendectomy for perforated appendicitis with abscess: a prospective, randomized trial. J Pediatr Surg. 2010 Jan;45(1):236-40. doi: 10.1016/j.jpedsurg.2009.10.039. — View Citation

Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granström L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. — View Citation

Yardeni D, Hirschl RB, Drongowski RA, Teitelbaum DH, Geiger JD, Coran AG. Delayed versus immediate surgery in acute appendicitis: do we need to operate during the night? J Pediatr Surg. 2004 Mar;39(3):464-9; discussion 464-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utility of initial nonoperative treatment of early appendicitis	Questionnaires given to parents and patients regarding their experience of initial nonoperative treatment and interval appendectomy will be analyzed, and compared with controls and with standard levels in the literature.; The Pediatric Quality of Life Scale-Version 4.0 (PedsQL) is a reliable and valid 23-item questionnaire that measures child health-related quality of life (QOL) in the preceding month. Items can be recoded from 100 to 0 on 25-point intervals and averaged to produce a total score (a=0.90). The total score is derived from items that assess the child's physical (e.g., problems with low energy or difficulty lifting something heavy), emotional (e.g., feeling afraid, angry, or scared), social (e.g., problems with getting teased or other children not wanting to be friends), and school functioning (e.g., problems paying attention in class or missing school). Higher scores indicate better QOL.	1 year	No
Primary	Number of treatment failures	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 tolerating a regular diet). The patient will then be considered having failed nonoperative treatment.	Worsening of symptoms at 8 hours or failure of improvement at 18 hours of treatment	Yes
Secondary	Cost-saving of initial nonoperative treatment for early appendicitis	Cost of nonoperative treatment will be calculated as follows: Hospitalization charges (# hospital days - observation) + costs of antibiotics (actual number of doses/days) + outpatient surgery hospital fee (operating room and PACU time) + additional costs associated with unanticipated events (e.g., Emergency room visits after initial discharge).; Control costs (contemporary data) will consider the following: Hospitalization charges (# hospital days) + intravenous antibiotics (price/dose x number of doses).	1 year	No