Is Interval Appendectomy Necessary?

Not Applicable

Terminated

• Conditions: Appendicitis
• Interventions: Procedure: Conservative Management; Procedure: Operative Management

• Registration Number: NCT01853683
• Lead Sponsor: Children's Hospital of Eastern Ontario

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-15
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative Management	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.
Operative Management	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.

Primary Outcome Measures

Name	Time	Method
Recurrent appendicitis for the conservative group	During a year of follow-up
Operative complications for the operative group	During a year of follow-up

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days

Trial Locations

Locations (1)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada