Is Interval Appendectomy Necessary?

Children's Hospital of Eastern Ontario

Status: Terminated

Conditions: Appendicitis

Treatments: Procedure: Conservative Management; Procedure: Operative Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01853683

13/02E

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Conservative Management

Experimental group

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.

Treatment:

Procedure: Conservative Management

Operative Management

Active Comparator group

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.

Treatment:

Procedure: Operative Management