Is Interval Appendectomy Necessary?

Children's Hospital of Eastern Ontario5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Appendicitis

Interventions

Conservative ManagementPROCEDURE

Operative ManagementPROCEDURE

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Recurrent appendicitis for the conservative group

Time frame: During a year of follow-up

Operative complications for the operative group

Time frame: During a year of follow-up

Secondary Outcomes

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

Data from ClinicalTrials.gov

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