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Is Interval Appendectomy Necessary?

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: NCT01853683
Recruitment Status : Terminated (Low recruitment)
First Posted : May 15, 2013
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Appendicitis Procedure: Conservative Management Procedure: Operative Management

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial
Study Start Date : April 2013
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Recurrent appendicitis for the conservative group [ Time Frame: During a year of follow-up ]
  2. Operative complications for the operative group [ Time Frame: During a year of follow-up ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT01853683


Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Ahmed Nasr, MD Children's Hospital of Eastern Ontario
More Information

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
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

Keywords provided by Ahmed Nasr, 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