Is Interval Appendectomy Necessary?

NCT01853683 | Terminated DMC

• 1 other identifier: 13/02E
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

General Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Conservative Management

EXPERIMENTAL

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.

Procedure: Conservative Management

Operative Management

ACTIVE COMPARATOR

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.

Procedure: Operative Management

Interventions

Conservative Management PROCEDURE

Conservative Management

Operative Management PROCEDURE

Operative Management

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Under 18 years of age
• Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ahmed Nasr, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

CA (1)