Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-institutional Trial of Non-operative Management of Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02271932
Recruitment Status : Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Comer Children’ Hospital
C.S. Mott Children's Hospital
James Whitcomb Riley Hospital for Children
Kosair Children’ Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
St. Louis Children's Hospital
American Family Children’s Hospital
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Peter Minneci, Nationwide Children's Hospital

Brief Summary:
A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.

Condition or disease Intervention/treatment
Appendicitis Other: Non-operative

Detailed Description:
Several randomized controlled trials comparing appendectomy to antibiotics alone in adults with acute appendicitis have been reported from non-U.S. countries. These studies reveal that non-operative management of appendicitis is a safe treatment for appendicitis and is associated with a significantly lower risk of complications than appendectomy. We have recently completed the first study in the U.S. examining the feasibility of non-operative management of uncomplicated appendicitis in children. In our pilot study, patients and their families chose between urgent appendectomy or antibiotics alone for treatment of uncomplicated appendicitis. The success rate of non-operative management was 90% at 30 days and 80% at a median follow-up of 8 months. In addition, patients in the non-operative group demonstrated a significantly faster return to normal activity and reported higher quality of life scores. The current proposal seeks to further investigate the effectiveness of non-operative management with antibiotics alone as a treatment option for children with uncomplicated appendicitis. When randomized trials are not feasible due to strong treatment preferences or when only a small proportion of patients will accept randomization, a parallel group non-randomized study where participants are allocated to their preferred treatment is a valuable alternative. Based on feedback from a multi-disciplinary stakeholder group that was convened to assess the potential impact of family preferences on study outcomes, recruitment, and generalizability, we propose a multi-institutional trial in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group). We hypothesize that non-operative management will be successful in 75% of patients at 1 year follow-up and will be associated with fewer disability days, higher quality of life scores, and lower costs than appendectomy. This study will enroll 795 patients, age 8-17 years, with uncomplicated appendicitis at 10 children's hospitals. The primary outcomes are: 1) differences in treatment-related disability between non-operative management and surgery in children with uncomplicated appendicitis across 10 children's hospitals; and 2) the success rate of non-operative management of uncomplicated appendicitis at 10 children's hospitals, defined as the percent of patients treated non-operatively who do not undergo an appendectomy. Secondary outcomes include differences between the groups in rates of complicated appendicitis, post-treatment related complications, disability days of the parent, quality of life and healthcare satisfaction measures, and total costs and the incremental cost-effectiveness of non-operative management relative to appendectomy. The proposed study will expand upon our previous pilot study by including patients from both freestanding and non-freestanding children's hospitals with both urban and rural demographies to determine the success rate and morbidity associated with non-operative management in a population that better represents the overall population of children in the U.S. Successful completion of this study may provide evidence for the effectiveness of non-operative management of uncomplicated appendicitis as an alternative first line therapy in children.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1076 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multi-institutional Trial of Non-operative Management of Uncomplicated Pediatric Appendicitis
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Surgery
Surgical management with appendectomy consists of hospital admission with initiation of intravenous antibiotics and urgent appendectomy .
Non-operative
Non-operative management consists of hospital admission for observation with a minimum of 24 hours of intravenous antibiotics and a minimum of 12 hours nil per os (NPO). With clinical improvement, patients are switched to oral antibiotics and discharged home with a prescription for oral antibiotics to complete a total antibiotic course of 7 days (including the duration of intravenous antibiotics).
Other: Non-operative
Patients will receive only antibiotics and will not undergo appendectomy unless they do not improve or their appendicitis recurs
Other Name: Non-operative management with antibiotics alone




Primary Outcome Measures :
  1. Success rate [ Time Frame: 1 year ]
    success rate at 1 year is percent of patients choosing non-operative management who have not undergone an appendectomy

  2. Disability Days [ Time Frame: 1 year ]
    Number of days without normal schedule


Secondary Outcome Measures :
  1. Perforated appendicitis [ Time Frame: 1 year ]
    percent of patients with perforated appendicitis at operation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with uncomplicated appendicitis
Criteria

Inclusion Criteria:

  • English and non-English speaking patients
  • Age : 8-17 years
  • US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon
  • White Blood Cell count > 5,000/µL and ≤ 18,000/µL
  • Abdominal pain ≤ 48hours prior to receiving antibiotics

Exclusion Criteria:

  • History of chronic intermittent abdominal pain
  • Pain > 48 hours prior to first antibiotic dose
  • Diffuse peritonitis
  • Positive urine pregnancy test
  • White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL
  • Presence of a fecalith on imaging
  • Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
  • Communication difficulties (e.g. severe developmental delay)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271932


Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Children's Hospital and Health System Foundation, Wisconsin
Comer Children’ Hospital
C.S. Mott Children's Hospital
James Whitcomb Riley Hospital for Children
Kosair Children’ Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
St. Louis Children's Hospital
American Family Children’s Hospital
Children's Hospital Medical Center, Cincinnati
Publications:
Layout table for additonal information
Responsible Party: Peter Minneci, Assistant Professor of Surgery and Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02271932    
Other Study ID Numbers: IRB14-00651
1507-31325 ( Other Grant/Funding Number: PCORI )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Minneci, Nationwide Children's Hospital:
appendicitis
non-operative management
children
pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents