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Is Interval Appendectomy Necessary?

Primary Purpose

Appendicitis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Conservative Management
Operative Management
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring General Surgery

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conservative Management

Operative Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrent appendicitis for the conservative group
Operative complications for the operative group

Secondary Outcome Measures

Duration of hospital stay

Full Information

First Posted
May 8, 2013
Last Updated
November 8, 2016
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01853683
Brief Title
Is Interval Appendectomy Necessary?
Official Title
Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
General Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Operative Management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conservative Management
Intervention Type
Procedure
Intervention Name(s)
Operative Management
Primary Outcome Measure Information:
Title
Recurrent appendicitis for the conservative group
Time Frame
During a year of follow-up
Title
Operative complications for the operative group
Time Frame
During a year of follow-up
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Nasr, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

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Is Interval Appendectomy Necessary?

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