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Perforated Appendicitis With Delayed Presentation

Primary Purpose

Appendicitis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Laparoscopic or open appendectomy
Expectant Management
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring laparoscopic appendectomy, open appendectomy, expectant management, paediatric

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Expectant Management

Operative management

Arm Description

Expectant Management

Operative management

Outcomes

Primary Outcome Measures

Length of stay in hospital

Secondary Outcome Measures

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
Time to full parenteral intake.
Duration of narcotics
Duration of antibiotics
Total dose or radiation exposure
Time to return to usual activity
Cost

Full Information

First Posted
February 11, 2010
Last Updated
June 5, 2018
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01068288
Brief Title
Perforated Appendicitis With Delayed Presentation
Official Title
Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit adequate number of patients
Study Start Date
July 2009 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
laparoscopic appendectomy, open appendectomy, expectant management, paediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectant Management
Arm Type
Experimental
Arm Description
Expectant Management
Arm Title
Operative management
Arm Type
Experimental
Arm Description
Operative management
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic or open appendectomy
Intervention Type
Procedure
Intervention Name(s)
Expectant Management
Intervention Description
A consult to Interventional Radiology will be made at the time of admission to determine whether percutaneous drainage is feasible, and if it is the abscess will be drained by Interventional Radiology. Ultrasound and/or CT scan will be used to follow the abscess collections and/or phlegmons and guide the removal of drains. For patients with a fecalith on imaging, a laparoscopic interval appendectomy will be performed 6-12 weeks following discharge from hospital. For those without a fecalith on imaging, a decision will be made by the family, with the guidance of the surgeon, whether or not to undergo a laparoscopic interval appendectomy.
Primary Outcome Measure Information:
Title
Length of stay in hospital
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
Daily until hospital discharge
Title
Time to full parenteral intake.
Time Frame
Daily until hospital discharge, 6 weeks, 12 months
Title
Duration of narcotics
Time Frame
Daily until hospital discharge, 6 months, 12 months
Title
Duration of antibiotics
Time Frame
Daily until hospital discharge, 6 weeks, 12 months
Title
Total dose or radiation exposure
Time Frame
All hospital visits until 12 months following initial discharge
Title
Time to return to usual activity
Time Frame
Daily until hospital discharge, 12 months
Title
Cost
Time Frame
12 months following initial discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Langer, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Perforated Appendicitis With Delayed Presentation

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