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TerminatedNCT01853683Updated Nov 10, 2016

Is Interval Appendectomy Necessary?

An interventional study of Conservative Management and Operative Management in Appendicitis, sponsored by Children's Hospital of Eastern Ontario. Terminated at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2016-11-10.

Sponsored by Children's Hospital of Eastern Ontario · Not applicable, Interventional, and Treatment

Why this study was terminated
Low recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Appendicitis

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Keywords

  • General Surgery
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 5 is below the median of 111 across 246 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Children's Hospital of Eastern Ontario is the lead sponsor of 83 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Conservative Management

  • Active comparator
    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.

    Procedure: Operative Management

Interventions

  • ProcedureConservative Management
  • ProcedureOperative Management
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What researchers measure

Primary outcomes

  1. Recurrent appendicitis for the conservative group

    Time frame: During a year of follow-up

  2. Operative complications for the operative group

    Time frame: During a year of follow-up

Secondary outcomes

  1. 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

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Study locations

1 site
  • Children's Hospital of Eastern Ontario
    Ottawa, Ontario K1H 8L1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01853683
Lead sponsor
Children's Hospital of Eastern Ontario
Responsible party
Ahmed Nasr (Principal Investigator, Children's Hospital of Eastern Ontario) — Principal investigator
First posted
May 15, 2013
Start date
Apr 2013
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Nov 10, 2016

Study contacts

Ahmed Nasr, MD
principal investigator · Children's Hospital of Eastern Ontario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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