Is Interval Appendectomy Necessary?

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Information provided by (Responsible Party):
Ahmed Nasr, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01853683
First received: May 8, 2013
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.


Condition Intervention
Appendicitis
Procedure: Conservative Management
Procedure: Operative Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Recurrent appendicitis for the conservative group [ Time Frame: During a year of follow-up ] [ Designated as safety issue: Yes ]
  • Operative complications for the operative group [ Time Frame: During a year of follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of hospital stay [ Time Frame: This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conservative Management
Children randomized to conservative management will be seen in the clinic 6-10 weeks after discharge and phoned to follow up every 3 month for a total follow-up of a year. Family will be instructed to come back to the hospital or call the treating physician if the child develops any abdominal pain or fever.
Procedure: Conservative Management
Active Comparator: Operative Management
Children randomized to IA will be scheduled for an interval appendectomy 6-10 weeks after discharge, and will be seen in the clinic 6-8 weeks following the interval appendectomy and phoned for follow-up every 3 month for a total of one year.
Procedure: Operative Management

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under 18 years of age
  • Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy

Exclusion Criteria:

  • Uncertainty about the diagnosis
  • The need for laparotomy/laparoscopy for another reason
  • Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
  • Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease
  • A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853683

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Ahmed Nasr       anasr@cheo.on.ca   
Principal Investigator: Ahmed Nasr         
Sub-Investigator: Juan Bass         
Sub-Investigator: Marcos Bettolli         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Ahmed Nasr, MD Children's Hospital of Eastern Ontario
  More Information

No publications provided

Responsible Party: Ahmed Nasr, Principal Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01853683     History of Changes
Other Study ID Numbers: 13/02E
Study First Received: May 8, 2013
Last Updated: May 24, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
General Surgery

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014