Is Interval Appendectomy Necessary?

Appendicitis Clinical Trial

Official title:

Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01853683
• Other study ID #: 13/02E
• Status: Terminated
• Phase: N/A
• First received: May 8, 2013
• Last updated: November 8, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Conservative Management

• Operative Management

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent appendicitis for the conservative group		During a year of follow-up	Yes
Primary	Operative complications for the operative group		During a year of follow-up	Yes
Secondary	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	No