Is Interval Appendectomy Necessary?

NCT ID: NCT01853683

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis

Keywords

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General Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Conservative Management

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Operative Management

Intervention Type PROCEDURE

Interventions

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Conservative Management

Intervention Type PROCEDURE

Operative Management

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Nasr

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

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Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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13/02E

Identifier Type: -

Identifier Source: org_study_id