Perforated Appendicitis With Delayed Presentation

Not Applicable

Terminated

• Conditions: Appendicitis
• Interventions: Procedure: Expectant Management; Procedure: Laparoscopic or open appendectomy

• Registration Number: NCT01068288
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.

Detailed Description

The ability of clinical practice guidelines to improve clinical practice and optimize resource utilization continues to be substantiated in the literature. To be effective, clinical practice guidelines must be developed from reliable and reproducible data.

This trial prospectively compares expectant management versus immediate laparoscopic or open appendectomy for perforated appendicitis in children with a delayed diagnosis. The primary outcome measure is length of hospital stay.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

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

Inclusion Criteria

• All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started.
• Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon.
• Consent to participate

Exclusion Criteria

• Uncertainty about the diagnosis.
• The need for laparotomy for another reason.
• Free intraperitoneal air on imaging.
• Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis.
• Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expectant Management	Expectant Management	Expectant Management
Operative management	Laparoscopic or open appendectomy	Operative management

Primary Outcome Measures

Name	Time	Method
Length of stay in hospital	2 years

Secondary Outcome Measures

Name	Time	Method
Complications recurrent abscess, recurrent admissions related to the disease,small bowel obstruction, injury to bowel, blood loss and transfusion requirement, failure of the conservative approach	Daily until hospital discharge
Time to full parenteral intake.	Daily until hospital discharge, 6 weeks, 12 months
Duration of narcotics	Daily until hospital discharge, 6 months, 12 months
Duration of antibiotics	Daily until hospital discharge, 6 weeks, 12 months
Total dose or radiation exposure	All hospital visits until 12 months following initial discharge
Time to return to usual activity	Daily until hospital discharge, 12 months
Cost	12 months following initial discharge

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada